speechespr查询

queryResult"Control#","RecdDate","From","Subject","Status""2020-1771","03/02/2020","FDAZILLA","2017-3189,2017-7796,2018-6566,2018-4546,2018-5033","Closed""2020-1772","03/02/2020","FDAZILLA","2017-9791,2017-9968,2018-6562,2018-3440,2017-7244","Closed""2020-1773","03/02/2020","FDAZILLA","2019-10836,2018-4842,2018-3908,2019-5440,2017-8601","Closed""2020-1774","03/02/2020","FDAZILLA","2018-7312,2017-4378,2017-5435,2017-5785,2019-4758","Closed""2020-1775","03/02/2020","DhanAI","2019-87132019-87142019-87152019-87162019-7402","Closed""2020-1776","03/02/2020","CenterforPharmaceuticalInformationandEngineeringResearchofPekingUniversity","1.
ZhejiangHaizhouPharmaceuticalCo.
,Ltd.
LinhaiCN1/18/20192.
ShandongLukangBiomanufacturingCo.
Ltd.
JiningCN1/24/20193.
ChangzhouPharmaceuticalFactoryChangzhouCN1/25/2019","Closed""2020-1777","03/02/2020","UNIVERSITYOFPENNSYLVANIA","recentinternalreviewbytheFDAofreportsofnephrogenicsystemicfibrosisinvolvingthefollowinggadolinium-basedcontrastagents:gadobenate,gadobutrol,gadoterate,andgadoteridol","Closed""2020-1778","03/02/2020","HeronTherapeutics,Inc.
","NDA022496,Supplement009forEXPAREL","Closed""2020-1779","03/02/2020","DhanAI","2019-73362019-73352019-77032019-77052019-7704","Closed""2020-1780","03/02/2020","BaronKarzaGroup","Pleaseprovidemeetingnotesandanydocumentation,notices,policiesoremailsbetweenCTPandCDERregardingsmokingcessationproducts,22ndCenturyGroup,orVLN(verylownicotine)inparticular.
","WithdrawnClosedw/oCharges""2020-1781","03/02/2020","DhanAI","2019-70722019-77012019-68132019-68102019-5939","Closed""2020-1782","03/02/2020","BhavishAgarwal","2019-73382019-73392019-73342019-67992019-7396","Closed""2020-1783","03/02/2020","PharmatechAssociates","BLAforTISSEEL,includingallsupplements.
","Hold""2020-1784","03/02/2020","RedlineCapitalPartners","Hiteam,HeronTherapeuticsreceivedaCRLfromtheFDAforHTX-011(fixeddoseformulationofbupivacaineandmeloxicam)inMay2019,withtheFDArequiringadditionalCMCandnon-clinicalinformationbeforeapprovingtheNDA.
Ibelieveaform483wasissuedinrespectoftheCMCrelatedissuesandIwouldpleaseliketogetacopyoftheform483andCRLletterissuedbytheFDABestregards","NotReasonablyDescribed""2020-1785","03/02/2020","USATODAY","2018-8231","Closed""2020-1786","03/02/2020","USATODAY","2019-8486","Closed""2020-1787","03/02/2020","ARENTFOXLLP","Nayzilamdrugapprovalpackage","Closed""2020-1788","03/02/2020","USATODAY","2019-6457","Closed""2020-1789","03/02/2020","USATODAY","2019-5900","Closed""2020-1790","03/02/2020","USATODAY","2019-6634","Closed""2020-1791","03/02/2020","USATODAY","2019-3033","Closed""2020-1792","03/02/2020","USATODAY","`","Closed""2020-1793","03/02/2020","USATODAY","2019-6664","Closed""2020-1794","03/02/2020","USATODAY","2018-4820","Closed""2020-1795","03/02/2020","ARENTFOXLLP","NayzilamandValtocoODDsandODEsandrelatedmemoranda/correspondence","Closed""2020-1796","03/02/2020","ARENTFOXLLP","Valtocodrugapprovalpackage","WithdrawnClosedw/oCharges""2020-1797","03/02/2020","NoelBrentConatser","FDA483forNorbrookLaboratoryNewry,NorthernIreland,UK.
Inspectionconductedin2020.
","AcknowledgementLetter""2020-1798","03/02/2020","FOIServices,Inc.
","2020-151","AcknowledgementLetter""2020-1799","03/02/2020","TaejoonPharmaceuticalCo.
,Ltd.
","1)KolmarKoreaCo.
,Ltd.
-BucheonFactory,3/22/2019,Form4832)HuonsCo.
,Ltd.
,10/18/2019,Form483","Closed""2020-1800","03/02/2020","Barr&Gulyas","2019-8443;Copiesofanyandallinformation,includingcorrespondence,exchangedbetweenthepharmacyValisureoranyofitsrepresentativesandtheFDAregardingZantacorRanitidinemadebetweenApril2019andOctober2019.
etc","Closed""2020-1801","03/02/2020","HBSS","Anytentativeorfinalroutingsheets,alongwithanytentativeorfinalapprovalletters,foranyANDAcitingApriso(mesalamine)astheRLD,includingbutnotlimitedtoANDANos.
204202,207272,107873,and209970.
","Closed""2020-1802","03/02/2020","USATODAY","2018-8313","Closed""2020-1803","03/02/2020","BraultGraham,LLC","Anyandallcertification,documentation,designations,invoices,verification,oranyotherrecordspertainingtotheRegenerativeMedicineandAdvancedTherapy(RMAT)designationandtheapprovalofsuchadesignationforMiMedx'sdrugAmniofix","AcknowledgementLetter""2020-1804","03/02/2020","FOIServices,Inc.
","CopiesofthedisclosableportionsofallcorrespondenceandinternalFDAmemosregardingthe2012DraftGuidanceonFerumoxytol","AcknowledgementLetter""2020-1805","03/02/2020","VERTICALPHARMACUETICAL","FormFDA483InspectionalObservationsforVivaPharmaceuticalInc.
,13880VikingPl,Richmond,V6V1K8,Canada,FEINumber3002704547.
Inspectionconducted1/6/2020to1/10/2020.
","Closed""2020-1806","03/02/2020","USATODAY","2019-7269","Closed""2020-1807","03/02/2020","FOIServices,Inc.
","2020-74","Closed""2020-1808","03/02/2020","FOIServices,Inc.
","2020-907","Closed""2020-1809","03/02/2020","THEASSOCIATEDPRESS","Allcorrespondenceanddocumentsto,from,andmentioningtheTennesseeDepartmentofCorrectionfrom6/1/2019untilpresent.
Somesearchkeywordsinclude,butarenotlimitedto,"midazolam,""vecuroniumbromide,""potassiumchloride,""pentobarbital,"and"fallingoutofsolution.
"","AcknowledgementLetter""2020-1810","03/02/2020","FreudLawP.
C.
","https://www.
accessdata.
fda.
gov/drugsatfda_docs/appletter/2012/020151s059,020699s100ltr.
pdfThisrequestisforthesupportivedocumentation,research,correspondenceORothersupportingdocumentationonwhichthisstatementisbased.
","WithdrawnClosedw/oCharges""2020-1811","03/02/2020","FOIServices,Inc.
","InformationregardingtheSodiumOxybateSharedREMSProgram.
Pleaseseeattached.
","AcknowledgementLetter""2020-1812","03/02/2020","FOIServices,Inc.
","2020-725","Closed""2020-1813","03/02/2020","FOIServices,Inc.
","FileNumbers2019-11782,2019-11795,2019-11796,2020-0093,and2020-0716","Closed""2020-1814","03/02/2020","CenterforScienceinthePublicInterest","advertisementsandpromotionallabelingmaterialssubmittedtotheFDAunder21C.
F.
R.
514.
80(5)(ii)","AcknowledgementLetter""2020-1815","03/02/2020","MeithealPharmaceuticalsInc.
","currentlabelingforANDA#080737(packageinsert,cartonandcontainerlabels).
","Closed""2020-1816","03/02/2020","TakedaPharmaceuticalsC/oRobertP.
BoninJr","PleaseprovidetheSummaryReview(SummaryBasisofApproval)forNDA206927/Original1,bortezomibforinjectionfortreatmentofadultpatientswithmultiplemyelomaandtreatmentofadultpatientswithmantlecelllymphomawhohavereceivedatleastonepriortherapy.
NDA206927wassubmittedbyDr.
Reddy'sLaboratoriesLtd.
onMay3,2019,andapprovedbyFDAonOctober4,2019.
","Closed""2020-1817","03/02/2020","CentrumBrokingLtd","BioconMalaysianFacilityForm483forInsulinGlargine-InspectionconductedbetweenFeb10thto21stFebruary2020","Closed""2020-1818","03/02/2020","J.
P.
MorganIndiaPrivateLimited","RequestforForm483ofPre-Approvalinspection(PAI)atBioconInsulinmanufacturingfacilitybasedinMalaysia,forInsulinGlargine,betweenFeb10andFeb21,2020.
","Closed""2020-1819","03/02/2020","MotilaloSwalSecuritiesLimited","Requestforform483withrespecttorecentusfdainspectionatunit12ofAurobindoPharma","Closed""2020-1820","03/02/2020","DrAjayPhadke","Form483forBioconBiologic'sMalaysiaPlant(3observations)Alkem'sBaddiUnit(2observations)CommunicationtoAurobindoonrescindingVAIonUNIT4","Closed""2020-1821","03/02/2020","EncubeEthicalsPvt.
Ltd.
","BACTROBAN(MUPIROCINCALCIUM)CREAM2%:NewDrugApplication(NDA):N050746-GLAXOSMITHKLINE-Container(tube)label(15gand30g),cartonlabel(15gand30g)andPatientInformationLeaflet","AcknowledgementLetter""2020-1822","03/02/2020","DrAjayPhadke","Form483forAurobindoUnit12","Closed""2020-1823","03/02/2020","COGENCYGLOBALINC.
","correspondencebetweentheFDAandMannPackingCompany,Inc.
,includingestablishmentinspectionsandnoticesofviolationsfromJanuary1,2017tothepresent","Closed""2020-1824","03/02/2020","RegistrarCorp","DiersInternationalGmbH'sMedicalDeviceEstablishmentfacilitywithregistration/FEInumber3006644670483","AcknowledgementLetter""2020-1825","03/02/2020","SparkCapitalAdvisors(I)PrivateLimited","483issuedbyUSFDAatBioconSdn.
Bhd'sinsulinformulationsmanufacturingfacilityinMalaysia.
Theinspectionwasconductedbetween10thFebto21stFeb2021.
FEInumberforthefacilityis3011248248.
","Closed""2020-1826","03/02/2020","BauschHealthCompaniesInc.
","SummaryofReviewsofSupplement12forNDA020688forPatanol(olopatadinehydrochloride),approvedMarch20,2000.
","Closed""2020-1827","03/02/2020","HSBCSecuritiesandCapitalMarkets(India)PrivateLimited","PleasesharetheForm483issuedtoBiocon'sinsulinmanufacturingfacilitybasedinMalaysiaafterrecentpre-approvalinspectionforinsulinglargine.
","Closed""2020-1828","03/02/2020","CitigroupGlobalMarketsIndiaPvtLtd","Form483issuedtoBioconSdn.
Bhd'sInsulinmanufacturingfacilitybasedinMalaysia","Closed""2020-1829","03/02/2020","IIMLucknow","RecentestablishmentinspectionreportsforAurobindoPharmaplantsespeciallyUnitIV","WithdrawnClosedw/oCharges""2020-1830","03/02/2020","LiveMint","Unit-4ofAurobindoPharmainTelanganabetweenNovember4-13,2019Form483issuedinNovember2019,theEIRissuedandtheletterrescindingtheEIR(3documents).
","WithdrawnClosedw/oCharges""2020-1831","03/02/2020","ROCHEMINTERNATIONALINC","FullyEIRAspirin-ShandongXinhuaPharmaceuticalCo.
,Ltd.
Address:HutianChemicalIndustrialZone,ZiboCity,ShandongProvince255075,China(CHN)API:Aspirin","Closed""2020-1832","03/02/2020","CONSUMERREPORTS","TheForm483issuedinresponsetoMcDanielLife-LineLLCforaninspectionbytheFDAthatoccurredbetweenNovember6–16,2018.
2)TheEIRissuedinresponsetoMcDanielLife-LineLLCforaninspectionbytheFDAthatoccurredbetweenNovember6–16,2018.
3)AnyandallcorrespondencebetweentheFDAandthecompanyinrelationtopoints#1and2.
","NotReasonablyDescribed""2020-1833","03/02/2020","FDAZILLA","2017-10261,2016-10393,2016-8831,2018-6612,2018-1741","Closed""2020-1834","03/02/2020","LATHAM&WATKINSLLP","TASIGNAETCORPHANPRODUCTSRECORDS","AcknowledgementLetter""2020-1835","03/02/2020","FDAZILLA","2019-10786,2019-10451,2019-10443,2019-1505,2019-2065","Closed""2020-1836","03/02/2020","FDAZILLA","2019-7219,2018-3611,2017-5629,2018-3916,2018-1067.
","Closed""2020-1837","03/02/2020","FDAZILLA","2018-3926,2019-7035,2018-2630,2017-8529,2017-3142.
","Closed""2020-1838","03/02/2020","BLOOMBERG","IwouldliketomakeanopenrecordsrequestforalistofIVF/fertilityfacilitiesbrokendownbyyearthatreceivedFDAform483sorawarningletterfromJanuary2015topresent","Closed""2020-1839","03/02/2020","Levi&Korsinsky,LLP","allmeetingminutesrelatedtotheNewDrugApplicationforbinimetinibsubmittedtotheFDAonoraroundJune30,2016andwithdrawnonorbeforeMarch19,2017,includinganyexhibitsorattachmentsthereto.
","AcknowledgementLetter""2020-1840","03/02/2020","RABONLAWFIRM,PLLC","1.
The"Safety-RelatedSupplementRequestletter"datedJune20,2019,sentbytheFDAtoEliLillyandCompany,andwhichisreferencedinParagraph2oftheletterentitled"SUPPLEMENTALAPPROVAL"forNDA021018/S-127andNDA021018/S-129,signedbyAnilRajpal,M.
D.
,M.
P.
H.
(forFDA)andaddressedtoIngridHensley(forEliLillyandCompany)etc","Closed""2020-1841","03/02/2020","UniversityofAlabamainHuntsville","IwouldliketogettheinformationontheInvestigationalNewDrug(IND)ApplicationsandINDapprovals/disapprovalsduringtheperiodof1985-2000.
","WithdrawnClosedw/oCharges""2020-1842","03/02/2020","King&SpaldingLLP","NDA018703","Closed""2020-1843","03/02/2020","AngelGohel","last5yearsofdrugrecalls;listofallapproveddrugsinthelasttwoyearsthathaveTHCasaningredient","WithdrawnClosedw/oCharges""2020-1844","03/02/2020","DSMNutritionalProducts,LLC","EstablishmentInspectionReport(EIR)forChemspecChemicalsPvt.
Ltd.
,Panvel,INDIA(FEI#3004947391)conductedBySaminaS.
Khan","Closed""2020-1845","03/02/2020","EASConsultingGroup,LLC","AllreleasableinformationofBiologicsLicenseApplication(BLA)No.
0568(forsourceplasma),submittedbyBloodandPlasmaResearch,Inc.
,approvedonDecember23,1974.
","AcknowledgementLetter""2020-1846","03/02/2020","WRAL-TV","totalnumberofadversereactionsreportedtotheFDAregardingthefleaandtickmedicationslistedbelow,startingfromAugust1,2018thrutoday,February25th2020MerckAnimalHealth(Bravecto):ElancoAnimalHealth(Credelio):BoehringerIngelheim(Nexgard):Zoetis(Simparica,RevolutionPlus)","AcknowledgementLetter""2020-1847","03/02/2020","AmandaChristman","Adverseeffectdataforeachofthefollowing:Neupogen,Granix,Nivestym,Zarxio","Closed""2020-1848","03/03/2020","NationalInstituteofsecuritiesMarkets","Form483ofBioconLtd'sMalaysianfacility,inspectedbetween10thFeb2020to21stFeb2020.
TheAddressoffacilityis-BioconSdn,Bhd,No1,jalan,Bioteknology,KawasanPerindustrianSiLC,79200Nusajaya,Joho,Malaysia","Closed""2020-1849","03/03/2020","Pathotrakinc","Roughnumberoffood-samplesfromtakenbytheFDAfromimportedgoods,toscreenforSalmonellaorListeriacontamination.
","Closed""2020-1850","03/03/2020","KeithMichaelPoliakoff","PERSONALRECS","NoRecord(s)""2020-1851","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:Cipla,Ltd.
MidcIndustrialAreaPatalganga,PlotNoA-2,A-33,A-37RaigadINDIA","Closed""2020-1852","03/03/2020","MaastrichtUniversityMedicalCenter","MEDICALDEVICES","AcknowledgementLetter""2020-1853","03/03/2020","AdvocateLutheranGeneralHospital","84995418776723100888771019026810515950111702861229474712301232127322011312140613790059","Closed""2020-1854","03/03/2020","BLOOMBERGNEWS","alldocumentsandrecordsprovidedbyJuulLabstoFDAinresponsetotheFDA'slettertoformerJuulCEOKevinBurnsonSeptember9,2019requesting"anyandalldocumentsandinformationthatJUULprovided,andthatJUULwillprovide,toCongressinresponsetotheJune7,2019,andApril8,2019,requests.
"","AcknowledgementLetter""2020-1855","03/03/2020","BLOOMBERGNEWS","copiesoftheattachmentsattachedtoanemaildatedApril11,2019fromRobinAppleberrytoEliseRichmanwiththesubject"FW:FOrour11AM","AcknowledgementLetter""2020-1856","03/03/2020","TimMarchman","Allfiles,reports,followupmaterials,referencestootheragencies,andanyotherrelatedmaterialsregardinginspectionsofStrange'sHoneyFarm,acompanyintheNOLdistrictwhoseinspectionenddatesaregivenintheInspectionClassificationDatabaseas12/02/11and07/01/16.
","Closed""2020-1857","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:CatalentIndiana,LLC1300S.
PattersonDr.
Bloomington,IN47403","Closed""2020-1858","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:NeurolignUSA,LLC128GammaDr.
,Pittsburgh,PA15238","Closed""2020-1859","03/03/2020","SuzanneApplegarth","Sample#854522","Closed""2020-1860","03/03/2020","AmberGerideau","PERSONALMEDICALISSUE","NotAnAgencyRecord""2020-1861","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:DiscusDentalLLC1700SBakerAve.
,SteAOntario,CA91761","Closed""2020-1862","03/03/2020","StephenSherman","NDA#018657SummaryBasisofApproval","Closed""2020-1863","03/03/2020","ReadyPacFoods,Inc","IamrequestingrecordsforForeignSupplierofRecordformycompany.
PleasesearchReadyPac,FoodsInc.
,ReadyPacFoods,ReadyPac,BonduelleFreshAmericas.
BonduelleboughtusbutIbelieveourlegalnameisstillReadyPacFoods,Inc.
WeneedtoknowifwearelistedastheForeignSupplierofrecordandwholistedusifweare","Closed""2020-1864","03/03/2020","Hyman,Phelps&McNamara,P.
C.
","PATCHMDRECS","NotReasonablyDescribed""2020-1865","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:TaroPharmaceuticalIndustrialIndustries,Ltd.
14,Ha-Kitor,BayHaifa,ISRAEL","Closed""2020-1866","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:DermaCareResearchLaboratories,LLC440FentressBlvd.
DaytonaBeach,FL32114","Closed""2020-1867","03/03/2020","EASConsultingGroup,LLC","AllreleasableinformationofBiologicsLicenseApplication(BLA)No.
1838(forsourceplasma),submittedbyHemarusLLC,approvedonSeptember11,2015.
","AcknowledgementLetter""2020-1868","03/03/2020","EASConsultingGroup,LLC","AllreleasableinformationofBiologicsLicenseApplication(BLA)No.
1881(forsourceplasma)submittedbyBPositiveNationalBloodServices,approvedonJanuary22,2014.
","AcknowledgementLetter""2020-1869","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:Sunnex,LLC8001TowerPointDr.
,Charlotte,NC28227","Closed""2020-1870","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:JubilantHollisterStier,LLC325NRegalSt.
,Spokane,WA99207","Closed""2020-1871","03/03/2020","RAYTHOMPSON","TheFDA-483documentfor:L.
PerrigoCompany13295ReflectionsDr.
,Holland,MI49424","Closed""2020-1872","03/03/2020","ANDRUSWAGSTAFFPC","ARENAPHARMS-BELVIQ,BELVIQXR(LORCASERIN)NDA22-529CORR,LBLGREVISIONS,MTGMINS,ETC","Closed""2020-1873","03/03/2020","CosettePharmaceuticals,Inc.
","SummaryBasisofApprovalforPOTASSIUMCITRATE(N019647)-10MEQ/PACKETand20MEQ/PACKET.
AtleastthemostrecentLabelandClinicalPharmacology","Closed""2020-1874","03/03/2020","KaiserHealthNews","allcorrespondence,memoranda,emailsandotherrecords,includingthoseofanymeetingsorenforcementaction,concerningadverseeventscausedbyCorceptTherapeutics'drugKorlym(NDA202107)sinceitsapprovalon2/17/2012topresent.
","AcknowledgementLetter""2020-1875","03/03/2020","KaiserHealthNews","thedisclosableportionsofallinternalFDAcorrespondence,aswellascorrespondencebetweentheFDAandCorcept,regardingadversereactionsforKorlym,from01/01/2017–12/31/2018","AcknowledgementLetter""2020-1876","03/03/2020","ABCNEWS","allcommunication,research/scientificevidence,publiccomments,andotherrecordspertainingtothedecisiontoreclassifytheelectroconvulsivetherapy(ECT)deviceon12/26/2018(DocketNo.
FDA-2014-N-1210).
","PartialResponse""2020-1877","03/03/2020","HAYESLAWOFFICESINC","NESTLECO/NESTLEGLOBAL-CHRONOBACTERFKAENTEROBACTERBACTERIUMININFANTFORMULARECS1/1/00TOPRESENT","AcknowledgementLetter""2020-1878","03/03/2020","NationalInstituteofSecuritiesMarkets,NaviMumbai","PleaseshareForm483forShilpaMedicareLtd'sfacilitylocatedatS-20toS-26,PharmaceuticalFormulationsSEZ,TSIIC,Jadcherla,TelanganaState,India,fortherecentinspectionfrom13-25,Feb2020.
","Closed""2020-1879","03/03/2020","CogencisInformationServices","WeneedaccesstotheForm483issuedbyFDAtoShilpaMedicareLtd'sfacilityatS-20toS-26,PharmaceuticalFormulationsSEZ,TSIIC,Jadcherla,TelanganaState,India.
","Closed""2020-1880","03/03/2020","KaiserHealthNews","2018-3258","Closed""2020-1881","03/03/2020","KaiserHealthNews","ThetwolettersthattheFDAreceivedinrelationtothedrugmifepristone,brandnameMifiprex,madebyDancoLaboratories,aboutthedrugmaker'sREMSprogram;andthetwolettersthattheFDAreceivedinrelationtothedrugmifepristone,brandnameKorlym,madebyCorceptTherapeutics.
"","AcknowledgementLetter""2020-1882","03/03/2020","KaiserHealthNews","2019-586;2018-9266;2018-7047;&2018-69192.
AnypostmarketingsurveillancereviewfromFDAOSEwrittenonKorlymorCorluxanddeathordiabetesoradrenalinsufficiencyorweightloss.
3.
All2253FormsrelatedtoKorlymorCorluxsubjecttodisclosure.
ETC","PartialResponse""2020-1883","03/03/2020","WILLIAMSCEDARLLC","MEDTRONIC-630GINSULINPUMPP15001,670GINSULINPUMPP160017CORRECTIVEANDPREVENTATIVEACTIONS,MDRS,SS&E,ETC","AcknowledgementLetter""2020-1884","03/03/2020","ARIZONADAILYSTAR","AccesstoandacopyoftheMedWatchVoluntaryReportingdatabase,includingbutnotlimitedtothefieldsintheMedWatchreportingform.
IamseekinganyincidentsinvolvingKratomforthepast5yearsinArizona.
","Closed""2020-1885","03/03/2020","MayerBrezis","adverseeventinformation","NotReasonablyDescribed""2020-1886","03/03/2020","DrAjayPhadke","Form483forShilpaMedicare'sJadcherlaUnitinTelengana15observations","Closed""2020-1887","03/03/2020","DrAjayPhadke","Form483forBiocon'sAPIFacilityInBengaluruAPIManufacturingFacilityat20thKM,BioconCampus,Bengaluru","Closed""2020-1888","03/03/2020","Genentech,Inc.
","-EntireunredactedSBAforXeljanz(tofacitinibcitrate),NDA203214/S-018,fortheindicationofmoderatelytoseverelyactiveulcerativecolitis(UC),approvedMay30,2018.
-EntireunredactedSBAforStelara(ustekinumab),BLA125261/S-152,fortheindicationoftreatmentofadultswithmoderatelytoseverelyactiveulcerativecolitis,approvedOctober18,2019.
","WithdrawnClosedw/oCharges""2020-1889","03/03/2020","siddharthkarnawat","weneedform483ofbioconinsulinmanufacturingfacilityinmalaysiainspectionhappendfrom10thfeb2020to21stfeb2020there3observationwereissued","Closed""2020-1890","03/03/2020","99CENTSONLYSTORESLLC","ENTRIESFORWHICHTHEWORD99CENTSONLYSTORESWASUSEDTOIDENTIFYTHEFOREIGNSUPPLIERVERIFICATIONPROGRAM(FSVP)","Closed""2020-1891","03/03/2020","CSPI","thecostsassessmentthatcontributedtothe"limitedcost-benefitanalysisoftheinterimandlong-termtargetmeanconcentrations"referencedonpage38,footnote37inFDA'sVoluntarySodiumReductionGoalsSupplementaryMemorandumtotheDraftGuidance:https://www.
regulations.
gov/documentD=FDA-2014-D-0055-0011,inwhichtheFDAsaid:Weconductedalimitedcost-benefitanalysisoftheinterimandlong-termtargetmeanconcentrations.
Thisanalysiswasbasedonahypotheticalscenarioinwhichallmembersofthefoodindustryvoluntarilychosetoadoptoursodiumreductiongoals.
Consideredcostsincludedlabeling,newingredients,andreformulation.
Benefitsincludedbothimprovementsinpublichealthaswellasdirectmedicalcostsavings.
Thisanalysissuggeststhereisasignificantnetbenefit.
","AcknowledgementLetter""2020-1892","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheSeattleDistrictOfficefromDecember1-31:","Closed""2020-1893","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheSanJuanDistrictOfficefromDecember1-31:","Closed""2020-1894","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheSanFranciscoDistrictOfficefromDecember1-31:","Closed""2020-1895","03/03/2020","FDANEWS","CopiesofForm483sissuedbythePhiladelphiaDistrictOfficefromDecember1-31:","Closed""2020-1896","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheMinneapolisDistrictOfficefromDecember1-31:","Closed""2020-1897","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheLosAngelesDistrictOfficefromDecember1-31:","Closed""2020-1898","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheKansasDistrictOfficefromDecember1-31:","Closed""2020-1899","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheFloridaDistrictOfficefromDecember1-31:","AcknowledgementLetter""2020-1900","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheNewYorkDistrictOfficefromDecember1-31:","Closed""2020-1901","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheDenverDistrictOfficefromDecember1-31:","Closed""2020-1902","03/03/2020","AmericanQueenSteamboatCompany","Information,documentation,investigationandorregulatoryfollow-uprelatedtothepassengervesselAmericanQueen(FEI#3010696218)andConsumerComplaint#1159838.
","AcknowledgementLetter""2020-1903","03/03/2020","TremeauPharmaceuticals,In.
c","TheOrphanDesignationrecordsfortocilizumab,whichwasdesignatedon07/31/2012.
","AcknowledgementLetter""2020-1904","03/03/2020","MacroGenics,Inc.
","FDAMulti-DisciplinaryReviewofSupplement005toNerlynx(neratinib)NDA208051foruseincombinationwithcapecitabine,forthetreatmentofadultpatientswithadvancedormetastaticHER2-positivebreastcancerwhohavereceivedtwoormoreprioranti-HER2basedregimensinthemetastaticsetting.
","WithdrawnClosedw/oCharges""2020-1905","03/03/2020","FDANEWS","CopiesofForm483sissuedbyCBERfromDecember1-31:","Closed""2020-1906","03/03/2020","MotilaloSwalSecuritiesLimited","Requestforform483withrespecttorecentUSFDAinspectionatJadcherlafacilityofShilpamedicare","Closed""2020-1907","03/03/2020","EisaiInc.
","LenvatinibNDANo.
206947/S-011,approvedbyFDAonSeptember17,2019.
IwouldliketoreceivethecompletedNDAMulti-disciplinaryReviewandEvaluation,alsorefereedtoasthe"AssessmentAid".
","WithdrawnClosedw/oCharges""2020-1908","03/03/2020","GreenbergTraurig,LLP","1.
AllcomplaintsinthepossessionoftheFDA,includingbutnotlimitedtothe121productcomplaintsinExhibitAregardingtheDevaCurlhairproductsDevaCurlOneCondition,DevaCurlLightDefiningGel,DevaCurlNo-PooOriginalcleanser,DevaCurlNo-PooDecadencecleanser,DevaCurlOneConditionDelighthair-conditioner,DevaCurlOneConditionDecadencehair-conditioner,andDevaCurlLeave-InDecadenceconditioner.
2.
AllcommunicationsbetweentheFDAandanynon-FDApersonnelregardingtheconsumercomplaintsidentifiedaboveinparagraph1.
","Closed""2020-1909","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheNewJerseyDistrictOfficefromDecember1-31:","Closed""2020-1910","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheChicagoDistrictOfficefromDecember1-31:","Closed""2020-1911","03/03/2020","HANCE&SRINIVASAN","INDIVIDUALRECS","WithdrawnClosedw/oCharges""2020-1912","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheCDRHfromDecember1-31:","AcknowledgementLetter""2020-1913","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheCDERfromDecember1-31:","Closed""2020-1914","03/03/2020","FDANEWS","CopiesofForm483sissuedbytheCDERfromDecember1-31:","Closed""2020-1915","03/03/2020","ANALYSISGROUP","SUPPLEMENTALAPRVLSOFBLINCYTO(BLINATUMAB)-APRVLLTRS,SUMMARYRVWS,STATISTICALRVWS,ETC","AcknowledgementLetter""2020-1916","03/03/2020","MCGUFFPHARMACEUTICALSINC","CSPCWEISNEGPAHRMACEUTICAL(SHIJANZHAUNG)COLTD-EIR2019","Closed""2020-1917","03/03/2020","HarringtonFilms","CDCEMPLOYEECOLINABASIER-EMAILS","Closed""2020-1918","03/03/2020","WASHINGTONPOST","ENDOPHARMS-SPECIALPROTOCOLASSESSMENTRELATINGTONDA21-610","AcknowledgementLetter""2020-1919","03/03/2020","WilsonSonsiniGoodrich&Rosati","NDA21-324-RVWS,STUDYEVALUATIONS","WithdrawnClosedw/oCharges""2020-1920","03/03/2020","WilsonSonsiniGoodrichRosati","NDA21-324/S018-RVWS","Closed""2020-1921","03/03/2020","QUARLES&BRADYLLP","CHEMRITECOPACINC,EDGEWOOD,WI-4836/6/16-7/15/16;WARNINGLTR6/27/17,CORR,ETC","AcknowledgementLetter""2020-1922","03/03/2020","QUARLES&BRADYLLP","SAGEPRODUCTSINC-RECALLRECS,CORR","AcknowledgementLetter""2020-1923","03/03/2020","QUARLES&BRADYLLP","SAGEPRODUCTSINC-RECALLEVENTID74970CORR","Hold""2020-1924","03/03/2020","QUARLES&BRADYLLP","SAGEPRODUCTSINC,CARY,IL-483,EIR6/2/16-9/1/16,CORR,ETC","Hold""2020-1925","03/03/2020","QUARLES&BRADYLLP","SAGEPRODUCTSINC-RECALLEVENTID77992CORR","Hold""2020-1926","03/03/2020","BLOODHURST&O'REARDONLLP","NATURE'SBOUNTYCO,REXALLSUNDOWNINC-APPLICATIONNUMBER2014-8475FORACERTIFICATEOFFREESALEOFOSTEOBI-FLEX","NoRecord(s)""2020-1927","03/03/2020","STERISCORP","INTEGRATEDMEDICALSYSTEMSINTERNATIONALINC,BIRMINGHAM,AL-4831/28/16","Closed""2020-1928","03/03/2020","JoshuaSharlin","TECHNICALDOCUMENTATIONCREATEDDURINGTHEIMPLEMENTATIONANDMAINTENANCEOFTHEFDAADVERSEEVENTREPORTINGSYSTEM","WithdrawnClosedw/oCharges""2020-1929","03/03/2020","STERISCORP","INTEGRATEDMEDICALSYSTEMSINTERNATIONALINC,HILLSBOROUGH,NJ-EIR2/25/16","Closed""2020-1930","03/03/2020","CLINREGCONSULTINGSERVICESINC","ALLERGAN-RESTASISNDA50-790/S024-CHEMISTRYRVWS","Closed""2020-1931","03/03/2020","DEBRAYAMANE","FEDERALPROTECTIVESERVICESEVENT19051796D","WithdrawnClosedw/oCharges""2020-1932","03/03/2020","B&HCONSULTINGSERVICESINC","PHARMACIAANDUPJOHN-DEPO-PROVERACONTRACEPTIVEINJNDA20-246SBA","Closed""2020-1933","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheNewEnglandDistrictOfficefromDecember1-31:","Closed""2020-1934","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheDetroitDistrictOfficefromDecember1-31:","Closed""2020-1935","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheDallasDistrictOfficefromDecember1-31:","Closed""2020-1936","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheCincinnatiDistrictOfficefromDecember1-31:","Closed""2020-1937","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheBaltimoreDistrictOfficefromDecember1-31:","Closed""2020-1938","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheAtlantaDistrictOfficefromDecember1-31:","Closed""2020-1939","03/04/2020","FDANEWS","CopiesofForm483sissuedbytheNewOrleansDistrictOfficefromDecember1-31:","Closed""2020-1940","03/04/2020","MonitorHealth","Wearelookingforlistofmaterials,appeals,ConsentForms,PatientRecords,PMASupplements","NotReasonablyDescribed""2020-1941","03/04/2020","MonitorHealth","K060057","AcknowledgementLetter""2020-1942","03/04/2020","LennhamPharmaceuticals,Inc.
","ReportsgeneratedbytheNationalCenterforToxicologicalResearch/NationalToxicologyProgram,specificallythefollowing:1.
AcutetoxicityreportoncaffeineinFisher344rats.
NCTRExperimentNo.
365(NTPExpt.
No.
0501101)(1982b)2.
AcutetoxicityreportoncaffeineinFisher344Rats,NCTRExperimentNo.
374(NTPExpt.
No.
0501102)(1982a)3.
90DaySubchronicReportonCaffeineinFisher344Rats.
FinalReport,NCTRTechn.
Rep.
forExpt.
No.
384(NTPExpt.
No.
05011-04)(1983)4.
14DayRepeatedDoseReportonCaffeine3,7-dihydro-1,3,7-trimethyl-1Hpurine-2,6-dioneinFisher344Rats,FinalReport,NCTRTechn.
Rep.
ForExpt.
No.
377NTPExpt.
No.
0501103.
","AcknowledgementLetter""2020-1943","03/04/2020","DamianAppliedToxicology,LLC","howFDAdevelopedtheacceptableintakeforNDMAinvalsartan-typedrugsof96ug/dayintheattachedFDAnewsreleasedatedFeb.
28,2019.
","NotReasonablyDescribed""2020-1944","03/04/2020","TAFTSTETTINIUS&HOLLISTERLLP","PatentlistingrequestForm3542forCYCLOSPORINE(RESTASISMULTIDOSE)EMULSION0.
05%submittedbyAllerganforNDANo.
N050790DearSir/Madam,WerespectfullyrequestthecopiesofthepatentlistingrequestForm3542forCYCLOSPORINE(RESTASISMULTIDOSE)EMULSION0.
05%submittedbyAllerganforNDANo.
N050790.
ThepatentslistedintheOrangeBookforNDANo.
N050790thatarethesubjectofthisrequestare:1.
U.
S.
PatentNo.
8,292,1292.
U.
S.
PatentNo.
8,561,8593.
U.
S.
PatentNo.
9,669,9744.
U.
S.
PatentNo.
9,676,525TheseformsweresubmittedtotheFDAonoraboutJune26,2017.
Regards,Roshan","AcknowledgementLetter""2020-1945","03/04/2020","KleinfeldKaplan&BeckerLLP","Allcorrespondence,meetingminutes,communications,memoranda,and/orotherdocumentationrelatedtoSulbutiamineanditsinclusiononFDA'sDietarySupplementAdvisoryList(foundathttps://www.
fda.
gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list);andAllcorrespondence,meetingminutes,communications,memoranda,and/orotherdocumentationrelatedtoFDA'sdecision-makingprocessfortheinclusionofingredientsspecifiedontheDietarySupplementAdvisoryList.
_x000D_","AcknowledgementLetter""2020-1946","03/04/2020","MonitorHealth","Wearelookingtoobtainmaterials,Appeals,ConsentForms,CertificationsofDocuments,PMASupplements,PatientRecords.
","NotReasonablyDescribed""2020-1947","03/04/2020","MeijerCompanies","allrecordsintheCustomsACEsystemwherethefollowingentitynames,thatareownedbyMeijer,arelistedintheFSVPImporterfield:FreshThymeFarmersMarket,LakesVentureLLC,andLakesVentureHoldingCompanyLLC.
","Closed""2020-1948","03/04/2020","ChocolateShoppeIceCreamCompany,Inc.
","SassyCowCreamery'sinspectionreports,recall,483report,andcorrectiveactionssubmitted.
","AcknowledgementLetter""2020-1949","03/04/2020","MEDEFILINC","ProductinsertofNDA019329-SODIUMCHLORIDE23.
4%INPLASTICCONTAINER,whichiscurrentlydiscontinuedandnotavailable.
","Closed""2020-1950","03/04/2020","FOIAGROUPINC","EX0000490:Deletionandadditionoffiltercenterlineandseamadhesive(fromMay2019)","AcknowledgementLetter""2020-1951","03/04/2020","ETNow","483forShilpaMedicare'sJadcherlafacility","Closed""2020-1952","03/04/2020","FOIServices,Inc.
","Knowledge-aidedAssessment&StructureApplication's(KASA)documenttemplates,revieweraidsandwork-aids,usedbyCDER/OPQforCMCreviewofNDAandBLAapplications.
","AcknowledgementLetter""2020-1953","03/04/2020","FOIServices,Inc.
","GMPuntitledlettersdatedonoraround01/27/2017&12/20/2019toWockhardt'sAurangabadShendraPlantinIndia","Closed""2020-1954","03/04/2020","MTFBIOLOGICS","MTFisrequestingallreferencesreviewedindevelopingthepoliciesrelatedtoadiposetissuethatareincludedtheFinalGuidance,RegulatoryConsiderationsforHumanCells,Tissues,andCellularandTissue-BasedProducts:MinimalManipulationandHomologousUse.
FederalRegisterVolume82,Number221(Friday,November17,2017)][RulesandRegulations][Pages54290-54292]","AcknowledgementLetter""2020-1955","03/04/2020","FOIServices,Inc.
","K003927,Y2000ManualResuscitator","AcknowledgementLetter""2020-1956","03/04/2020","AlmacPharmaServices","EIRfortheinspectionperformedattheAlmacPharmaServicesLLClocatedat2661AudubonRoad,Audubon,PA19403(FEINo.
3000214934).
","Delogged(notaFOIARequest)""2020-1957","03/04/2020","SusieM.
V.
","congressionalresponserecs","Closed""2020-1958","03/04/2020","Xproassociates,LLC","483issuedtoFujiYakuhinatToyama,JapanonFDACDERInspection(191126,km-3)","Closed""2020-1959","03/04/2020","LebanonVAMedicalCenter","Needacopyofthe2017FDARegistrationfortheUniversityofMiamiTissueBank.
","AcknowledgementLetter""2020-1960","03/04/2020","CentrumBrokingLtd","Form483Twoobservation-PostapprovalandGMPinspectionofSmallMoleculesAPIManufacturingfacilityat20thKM,BioconCampus,Bengalarubetween20th-26thFeb,2020","Closed""2020-1961","03/04/2020","EducationforAll","483issuedtoShilpaMedicareJadcherlaUnitTelanganaIndia","Closed""2020-1962","03/04/2020","MerckAnimalHealth","MerckAnimalHealthiscurrentlyperusingtodevelopgenericofExcede(NADA141-209).
Therefore,wearerequestingCVMtoprovideusacopyoftheregulatoryresiduemethodforExcede(CeftiofurCrystallineFreeAcid)forBeef,Non-lactating,andLactatingDairy.
","Closed""2020-1963","03/04/2020","WilliamAndres","Neurobehavioraladversereactionsreportstomedicinescontainingaspartame,suchastheantipsychoticmedicationZyprexa","Closed""2020-1964","03/04/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Decatur,ILlocation(3005484053)December4,2019-December6,2019.
","Delogged(notaFOIARequest)""2020-1965","03/04/2020","AirisPharmaInc","AMICAR(aminocaproicacid)Oralsolution,NDA#N015230WerequestyousharetheReferenceListedDrug(RLD)reviewinformationi.
e.
,SummaryBasisofApproval(SBOA)includingClinicalpharmacologyandBiopharmaceuticsreview.
","Closed""2020-1966","03/04/2020","MankindPharmaLtd.
","RequestforApprovedDocumentsofPrednisoloneAcetateOphthalmicSuspension,USP1.
0%-NDANo.
017469","Closed""2020-1967","03/04/2020","BLOODHURST&O'REARDONLLP","NATURESBOUNTYCO-CORRBETWEENFDA1/12014TO1/2015","DuplicateRequest""2020-1968","03/04/2020","EDENCHANE","ANDA203760APRVL","Closed""2020-1969","03/04/2020","LINDASGOURMETLATKES","LINDASGOURMENTLATKES,VANNUYS,CA-EIR6/26/19","Closed""2020-1970","03/04/2020","PRICEMEESEATAL","NUNEZRAMOSIMPYEXP.
SRL-CORR1/1TO12/18","Hold""2020-1971","03/04/2020","PRICEMEESEATAL","BLUELEAFINTLSRL-CORR1/16TO12/18","Hold""2020-1972","03/04/2020","PRICEMEESEATAL","CONGELADOSDELCIBAO-CORRREGARDINGRIOHAINADOMINICANREPUBLICTONYFOR3KIDSCORP","Hold""2020-1973","03/04/2020","WILSONSONSINIETAL","NDA021035/S102-APRVL","AcknowledgementLetter""2020-1974","03/04/2020","HALL&COLLINSINJURYLAW","ZIMMERBIOMETINC-REGENEREXPATELLAK083782","AcknowledgementLetter""2020-1975","03/04/2020","CONWAYHOMERPC","INDIVIDUALRECS","AcknowledgementLetter""2020-1976","03/04/2020","BAKER&HOSTETLER,LLP","NDA017054-ANNUALRPTS,SUPPLEMENTS","WithdrawnClosedw/oCharges""2020-1977","03/04/2020","AmericanOversight","HHSDIRECTIVESREGARDINGCORONAVIRUS","AcknowledgementLetter""2020-1978","03/04/2020","JEFFCHANG","NINGBOHUIZECOMMODITYCO-WARNINGLTRRESP","NoRecord(s)""2020-1979","03/04/2020","SAEN","A&GPHARMACEUTICALINC,BIOMEDICALRESEARCHINSTITUTE,BIOQUALINC,ETC-CORR10/31/19TO1/31/20","AcknowledgementLetter""2020-1980","03/05/2020","AmericanOversight","ASBESTOSCONFIRMATIONTESTRECS","NoRecord(s)""2020-1981","03/05/2020","AmericanOversight","ASBESTOSCOMMUNICATIONSWITHJOHNSONANDJOHNSON,OSHA,ETC","NoRecord(s)""2020-1982","03/05/2020","LukeZabawa","internalpracticeoftheiPledgeprogram","WithdrawnClosedw/oCharges""2020-1983","03/05/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-779,2018-9582,2018-7291,2018-4101,2018-8070.
Pleaserefertoourcontrolnumber6210311inyourreply.
","Closed""2020-1984","03/05/2020","CapstoneDevelopmentCompany","Listofthe21drugsandthe63medicaldevicemanufacturersdiscussedintheFebruary27,2020,FDAupdate.
","NotReasonablyDescribed""2020-1985","03/05/2020","FOIServices,Inc.
","2018-8213,2018-9633,2018-3348,2018-8035,2019-563","Closed""2020-1986","03/05/2020","FOIServices,Inc.
","2019-576,2019-566,2018-9632,2018-9631,2019-577","Closed""2020-1987","03/05/2020","FOIServices,Inc.
","2019-4055,2019-4045,2018-8602,2018-3762,2018-1422.
","Closed""2020-1988","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:SonicSystemsIncIvyland,PAEndDatesofinspection:26September2019FDADistrictOffice:PhiladelphiaDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-1989","03/05/2020","DrAjayPhadke","Form483forDrReddysBachupallyUnit-2observationsShilpaMedicare-15observationsJadcherlaUnitTelengana","Closed""2020-1990","03/05/2020","EncubeEthicalsPrivateLimited","ANDA087355","Closed""2020-1991","03/05/2020","FOIServices,Inc.
","correspondencebetweenOfficeoftheCommissionerandstateofFlorida,regardingFDA'sproposedruleon'"ImportationofPrescriptionDrugs,"Florida's"CanadianPrescriptionDrugImportationConceptPaper,"orFlorida's"ActRelatingtoPrescriptionDrugImportationPrograms"(FloridaHB19).
","AcknowledgementLetter""2020-1992","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:IsorxCorpRichmond,CAEndDatesofinspection:18September2019FDADistrictOffice:SanFranciscoDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-1993","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:AmperorInc.
Houston,TXEndDatesofinspection:29October2019FDADistrictOffice:DallasDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-1994","03/05/2020","TaxpayersProtectionAllianceFoundation","listofattemptsmadebycompaniestotheFoodandDrugAdministration(FDA)forassistanceinthepreparationofPremarketTobaccoProductApplications(PMTAs).
","AcknowledgementLetter""2020-1995","03/05/2020","FDAZILLA","TheResponse(inelectronicformat)forHumanDrugsinspectionofPatheonAPIServicesInc.
ending04/12/2019atthelocationinFlorenceSC,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofIQVIAending04/12/2018atthelocationinDurhamNC,UnitedStates.
TheResponse(inelectronicformat)forHumanDrugsinspectionofIQVIAending04/12/2018atthelocationinDurhamNC,UnitedStates.
TheResponse(inelectronicformat)forHumanDrugsinspectionofIQVIAending11/08/2018atthelocationinDurhamNC,UnitedStates.
Pleasesenddocumentsasemailattachments.
","AcknowledgementLetter""2020-1996","03/05/2020","CONSUMERREPORTS","AnyandallrecordstosufficientlydescribehowtheFDAissupposedtorespondtoanadverseeventreportintheCAERSdatabase,suchasaninternalguide,employeehandbook,memo,ormore.
","NoRecord(s)""2020-1997","03/05/2020","FOIServices,Inc.
","CorrespondenceregardinginteractionsbetweenFDA&stateofFloridaonregardingprescriptiondrugimportation01/01/2018-Present.
","NotReasonablyDescribed""2020-1998","03/05/2020","FDAZILLA","TheEIR(inelectronicformat)forAnimalDrugs&FeedsinspectionofCiplaLimitedending09/27/2019atthelocationinVascoDaGama,India.
TheResponse(inelectronicformat)forAnimalDrugs&FeedsinspectionofCiplaLimitedending09/27/2019atthelocationinVascoDaGama,India.
","AcknowledgementLetter""2020-1999","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:InvaGenPharmaceuticals,Inc.
Hauppauge,NYEndDatesofinspection:06December2019FDADistrictOffice:NewYorkDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2000","03/05/2020","FOIServices,Inc.
","FileNumbers2019-10741,2019-11897,and2020-0700","Closed""2020-2001","03/05/2020","KellyEmanuel","informationfromtheFDA/CBERthatwouldfulfilltheirresponsibilitytomeetthereportingrequirementsofNCVIAof1986(42Code300aa27a-c),ETC","AcknowledgementLetter""2020-2002","03/05/2020","ARDGermanTV","Allreports,lettersandmemosregardingtheinspectionsofplasmapheresiscentersintheofficialborderareatoMexico,definedaswithin62milesoftheU.
S.
-Mexicanborder","AcknowledgementLetter""2020-2003","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:GURINPRODUCTSLLCTustin,CAEndDatesofinspection:08November2019FDADistrictOffice:LosAngelesDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2004","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:APNHealthLLCWaukesha,WIEndDatesofinspection:10October2019FDADistrictOffice:MinneapolisDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2005","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:GibraltarLaboratories,Inc.
Fairfield,NJEndDatesofinspection:07November2019FDADistrictOffice:NewOrleansDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2006","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:CSLPlasma,Inc.
Jackson,MSEndDatesofinspection:18November2019FDADistrictOffice:NewOrleansDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2007","03/05/2020","BURGSIMPSONELDREDGEHERSHJARDINEPC","(1)AllConsentOrdersenteredinCarsonProducts,etalv.
DepartmentofHealthandHumanServices,etal.
,No.
CV480-71(SouthernDistrictofGeorgia).
(2)AllSettlementAgreementsandConsentAgreementsbetweenthepartiesinCarsonProducts,etalv.
DepartmentofHealthandHumanServices,etal.
,No.
CV480-71(SouthernDistrictofGeorgia).
(3)AlltranscriptsofspeechesattheannualmeetingsoftheFoodandDrugLawInstitutefrom1980and1982discussingthetermsoftheConsentOrderinCarsonProducts,etalv.
DepartmentofHealthandHumanServices,etal.
,No.
CV480-71(SouthernDistrictofGeorgia).
(4)AllwrittenmaterialsdistributedattheannualmeetingsoftheFoodandDrugLawInstitutefrom1980and1982discussingthetermsoftheConsentOrderinCarsonProducts,etalv.
DepartmentofHealthandHumanServices,etal.
,No.
CV480-71(SouthernDistrictofGeorgia).
","NotAnAgencyRecord""2020-2008","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:CelesticaOregon,LLC.
Portland,OREndDatesofinspection:25October2019FDADistrictOffice:SeattleDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2009","03/05/2020","RegistrarCorp","spreadsheetdetailingthenumberoffoodfacilitiesregisteredineachprovinceofChinaasofDecember31,2019","Closed""2020-2010","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:CaliberImagingandDiagnostics,Inc.
Rochester,NYEndDatesofinspection:10October2019FDADistrictOffice:NewYorkDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2011","03/05/2020","ThomsonReuters-ClarivateAnalytics","FormFDA483:BryantRanchPrepack,Inc.
dbaBRPPharmaceuticalsBurbank,CAEndDatesofinspection:18November2019FDADistrictOffice:LosAngelesDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2012","03/05/2020","VATTInstituteforEconomicResearch","8ANDAapprovalletters.
","Closed""2020-2013","03/05/2020","BrandonMartin","INDIVIDUALRECS","Closed""2020-2014","03/05/2020","BrandonMartin","BioterrorismActof2002,FoodSafetyModernizationAct,IamrequestinganyBioterrorismActof2002orFoodSafetyModernizationActreportsforParagonFoods(years2016-2020)whichislocatedat173ThornHillRd,Warrendale,PA15086(724)741-9100ThepreviousaddressforParagonFoods(2000-2016)was5536thStPittsburgh,PA15201MyNameisBrandonMartin412893-6196Myaddressis4885AMcknightRd#140","NoRecord(s)""2020-2015","03/05/2020","IPDANALYTICSLLC","Pleaseconsiderthisarequestforacopyofthe6/19/19tentativeapprovalletterforANDANo.
210225forIvermectin(genericdrug).
Pleaseconsiderthisarequestforacopyofthe2/12/20tentativeapprovalletterforANDANo.
208417forKetorolac;Phenylephrine(genericdrug).
Pleaseconsiderthisarequestforacopyofthe2/14/20tentativeapprovalletterforANDANo.
212182forFluvoxamineMaleate(genericdrug).
Pleaseconsiderthisarequestforacopyofthe2/18/20tentativeapprovalletterforANDANo.
211593forPregabalin(genericdrug).
Pleaseconsiderthisarequestforacopyofthe3/8/19tentativeapprovalletterforANDANo.
209790forTofacitinib(genericdrug).
Pleaseconsiderthisarequestforacopyofthe2/19/20effectiveapprovalletterforANDANo.
208637forOlopatadineHydrochloride(genericdrug).
Pleaseconsiderthisarequestforacopyofthe2/21/20effectiveapprovalletterforANDANo.
212983forNicotinePolacrilex(genericdrug).
Pleaseconsiderthisarequestforacopyofthe8/8/19effectiveapprovalletterforANDANo.
209578forZoledronicAcid(genericdrug).
ThesedocumentsarenotcurrentlyavailableontheDrugs@FDAwebsite.
","Closed""2020-2016","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:VIAChristiRegionalMedCntrWichita,KSEndDatesofinspection:18November2019FDADistrictOffice:KansasDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2017","03/05/2020","BrandonMartin","HAACPcomplaints","NotReasonablyDescribed""2020-2018","03/05/2020","ThomsonReuters-ClarivateAnalytics","FormFDA483:UniqueInstruments,Inc.
Bridgeport,MIEndDatesofinspection:05September2019FDADistrictOffice:DetroitDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2019","03/05/2020","UNIVERSITYOFSOUTHERNCALIFORNIA","Two510(k)submissionpackages:K150852andK180068.
","AcknowledgementLetter""2020-2020","03/05/2020","BrandonMartin","PleasesendallHACCPcomplaints,complaints,citations,forParagonFoods(years2016-2020)whichislocatedat173ThornHillRd,Warrendale,PA15086(724)741-9100ThepreviousaddressforParagonFoods(2000-2016)was5536thStPittsburgh,PA15201","NoRecord(s)""2020-2021","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:DermaPharmA/S,Farup,DenmarkInspectionenddate:19September2019FDADistrictOffice:CenterforDrugEvaluationandResearchDistrictDecision:OAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2022","03/05/2020","KellyEmanuel,MPH","IamrequestinganyandallFDAqualitycontrol,qualityassurancetestingand/orinspectionreportsforindividualsamplesandthefacilitiesthatmanufactureGardasilforthemarketingauthorizationholderSanofiPasteurMSD,thejointventureofMerckandSanofi-AventisSA.
Gardasilwasfirstapprovedforusein2006.
ThereistestingthatindicatespotentialcontaminantsinGardasilvaccines.
Pleaseseepage5ofreporthttp://medcraveonline.
com/IJVV/IJVV-04-00072.
pdf","AcknowledgementLetter""2020-2023","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:Nature'sNaturalProducts,INC.
DBANature'sSkinandBodyFoodNashville,TNEndDatesofinspection:27September2019FDADistrictOffice:NewOrleansDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2024","03/05/2020","BrandonMartin","PleasesendmeanyHazardAnalysisCriticalControlPoint(HACCP)reports,incidents.
","NotReasonablyDescribed""2020-2025","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:NetechCorp.
Farmingdale,NYEndDatesofinspection:08October2019FDADistrictOffice:NewYorkDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2026","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:Ortho&SurgicalSolutions,Inc.
Guaynabo,PREndDatesofinspection:22November2019FDADistrictOffice:SeattleDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2027","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:Ortho&SurgicalSolutions,Inc.
Guaynabo,PREndDatesofinspection:22November2019FDADistrictOffice:SeattleDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","DuplicateRequest""2020-2028","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:OcuMetrics,Inc.
MountainView,CAEndDatesofinspection:12December2019FDADistrictOffice:SanFranciscoDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2029","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:NovoSciCorporationConroe,TXEndDatesofinspection:07November2019FDADistrictOffice:DallasDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2030","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:NextHealth,LLCNorwalk,CTEndDatesofinspection:07November2019FDADistrictOffice:NewOrleansDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2031","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:NationalAdvancedEndoscopyDevicesIncCanogaPark,CAEndDatesofinspection:30August2019FDADistrictOffice:LosAngelesDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","AcknowledgementLetter""2020-2032","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:TheMicroConnectionEnterprises,Inc.
DBAPersonalCarePerformanceGroupCityOfIndustry,CAEndDatesofinspection:30October2019FDADistrictOffice:LosAngelesDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","AcknowledgementLetter""2020-2033","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:MedtronicNeuromodulationMinneapolis,MNEndDatesofinspection:10October2019FDADistrictOffice:MinneapolisDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2034","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:Linatech,LlcSunnyvale,CAEndDatesofinspection:08November2019FDADistrictOffice:SanFranciscoDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2035","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:PretikaCorporationLagunaNiguel,CAEndDatesofinspection:25October2019FDADistrictOffice:LosAngelesDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2036","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:TrigenLaboratories,Inc.
Tampa,FLEndDatesofinspection:15November2019FDADistrictOffice:FloridaDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2037","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:SCLHealthIRBBroomfield,COEndDatesofinspection:07November2019FDADistrictOffice:DenverDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2038","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:RogerS.
Keresztes,M.
D.
StonyBrook,NYEndDatesofinspection:27September2019FDADistrictOffice:NewYorkDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2039","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:QualitelCorporationEverett,WAEndDatesofinspection:05December2019FDADistrictOffice:SeattleDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","DuplicateRequest""2020-2040","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:HawParHealthcareLimited,SingaporeInspectionenddate:01March2019FDADistrictOffice:CenterforDrugEvaluationandResearchDistrictDecision:OAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2041","03/05/2020","EncubeEthicalsPrivateLimited","Followinginformationstoberequiredforgenericdevelopmentandtodecidefilingstrategy.
ProprietaryName:ADAPALENETOPICALGEL,0.
1%ApplicationNumber:A091314(ApprovalDate:Jul9,2019)MarketingStatus:Over-the-counterInformationneededasbelow:1.
Approvalletter2.
Productcorrespondence3.
Tubeandcartonlabels","Closed""2020-2042","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:QualitelCorporationEverett,WAEndDatesofinspection:05December2019FDADistrictOffice:SeattleDistrictDistrictDecision:VAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2043","03/05/2020","ThomsonReuters-ClarivateAnalytics","AspermittedbytheFreedomofInformationAct(FOIA),Iamherebyrequestingthefollowingdocument:FormFDA483:LantechPharmaceuticalsLimited,Chittivalasa,IndiaInspectionenddate:15March2019FDADistrictOffice:CenterforDrugEvaluationandResearchDistrictDecision:OAIIconfirmthatClarivateAnalyticswillbechargedaccordinglybyFOIforthisrequest,howeverpleasecontactmeifthechargesexceed$200.
","Closed""2020-2044","03/05/2020","ROBERTWOOTON","TRAZODONE-AER","Delogged(notaFOIARequest)""2020-2045","03/05/2020","VENABLELLP","K191547,K182960,K173233","AcknowledgementLetter""2020-2046","03/05/2020","WILSONSONSINIETAL","NDA021324S/10,11RVW","Closed""2020-2047","03/05/2020","HARRISSPICECOMPANYINC","ENTRYNOERH-0006271-9","Closed""2020-2048","03/05/2020","GLOBALRESEARCHPARTNERS&CONSULTANTSINC","FEI3014823873","Closed""2020-2049","03/05/2020","LIPSITZANDPONTERIOLLC","XELJANZXR-15103996,15014453,13755714,13749123AER","Closed""2020-2050","03/05/2020","MCKEEN&ASSOCIATESPC","USSTEMCELLCLINICLLC,WESTON,FL-INVESTIGATIONS","PartialResponse""2020-2051","03/05/2020","BUSINESSADVOCATELAWPLLC","CBD-AER","AcknowledgementLetter""2020-2052","03/06/2020","FOIServices,Inc.
","listofabout150drugsthatareatriskofshortageifthecoronavirusoutbreakinChinaworsens.
","AcknowledgementLetter""2020-2053","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRinspectionthatwasconductedinourCSLPlasma,Inc.
-Albuquerque,NM(3011473061)November5,2019-November7,2019.
","Delogged(notaFOIARequest)""2020-2054","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Halethorpe,MDlocation(3012983617)August15,2019-August16,2019.
","Delogged(notaFOIARequest)""2020-2055","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma.
Inc.
-Mechanicsburg,PAlocation(3013001685)August19,2019-August30,2019.
","Delogged(notaFOIARequest)""2020-2056","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Philadelphia,PAlocation(3011816262)July23,2019-August5,2019","Delogged(notaFOIARequest)""2020-2057","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Smyrna,GAlocation(3010890818)November5,2019-November7,2019.
","Delogged(notaFOIARequest)""2020-2058","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Lakeland,FLlocation(3012229709)November5,2019-November7,2019","Delogged(notaFOIARequest)""2020-2059","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Taylor,PAlocation(3015196939)October22,2019-October24,2019.
","Delogged(notaFOIARequest)""2020-2060","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAInspectionthatwasconductedinourCSLPlasma,Inc.
-McKeesport,PAlocation(3013771915)November12,2019-November14,2019","Delogged(notaFOIARequest)""2020-2061","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
Columbus,OH(3011893716)July11-July18,2019.
","Delogged(notaFOIARequest)""2020-2062","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAInspectionthatwasconductedinourCSLPlasma,Inc.
-TempleTerrace,FLlocation(3015216535)September23,2019-September25,2019","Delogged(notaFOIARequest)""2020-2063","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Cincinnati,OHlocation(3013154069)November5,2019-November8,2019.
","Delogged(notaFOIARequest)""2020-2064","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Jackson,MSlocation(3012227885)November13-November18,2019.
","Delogged(notaFOIARequest)""2020-2065","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAinspectionthatwasconductedinourCSLPlasma,Inc.
-Toledo,OHlocation(3013157729)November18,2019-November22,2019.
","Delogged(notaFOIARequest)""2020-2066","03/06/2020","CSLPlasma,Inc.
","RequestingacopyoftheFDAEIRfromanFDAInspectionthatwasconductedinourCSLPlasma,Inc.
-Westwego,LAlocation(3012118618)September17,2019-September18,2019.
","Delogged(notaFOIARequest)""2020-2067","03/06/2020","SandraRothenberg","PremarketTobaccoProductApplicationsforelectroniccigarettessubmittotheFDAin2018and2019.
WewouldalsolikecopiesofanySubstantialEquivalenceReportsforelectroniccigarettessubmittotheFDAin2018and2019.
","ClosedDenial""2020-2068","03/06/2020","DreaMedDiabetesLtd.
","Seekingallrecordsrelatedto510K:K190487(i.
e.
originalsubmission,FDArequestforadditionalinformation,applicantresponseetc.
).
","AcknowledgementLetter""2020-2069","03/06/2020","UnitedSafetyAgentsLLC","recordscontaininganyofthefollowinginformationforentriesmadebetweenFebruary01,2020,toFebruary29,2020:I.
RecordsforwhichtheFSVPImporter'sUFIorDUNSis08-08-01169;II.
RecordsforwhichtheFSVPImporter'sFederalTaxIDis82-2349285;III.
RecordsthatnameUnitedSafetyAgents,orClaudioInnocenti,orvariationsofthesame,astheFSVPImporter;IV.
RecordsforwhichtheFSVPImporter'saddressis715WestParkAve.
,Oakhurst,NJ07755;V.
RecordsforwhichtheFSVPImporter'selectronicmailingaddresscontains@unitedsafetyagents.
com.
","Closed""2020-2070","03/06/2020","MeganSchnur","SearchingCVM'sADEdatabaseforadverseeventsinUSassociatedwithceftiofurhydrochloride(specifically,ExcenelRTUEZ)inallspeciesforMarch2018throughFebruary2019.
CVMADEComprehensiveClinicalDetailReportListingforceftiofurhydrochloride(ExcenelRTUEZ)forMarch2018-February2019.
","AcknowledgementLetter""2020-2071","03/06/2020","AmericanOversight","DAILYBRIEFINGSORSITUATIONRPTSPREPAREDFOR,OROTHERWISEPROVDEDTO,AGENCYLEADERSHIPREGARDINGTHEONGOINGCORONAVIRUSOUTBREAK","AcknowledgementLetter""2020-2072","03/06/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofSmith&Nephew,Inc.
ending03/26/2015atthelocationinAndoverMA,UnitedStates.
The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofChristopherJ.
Hartnick,MDending06/28/2019atthelocationinBostonMA,UnitedStates.
","Closed""2020-2073","03/06/2020","FreseniusKabi","LatestapprovedandmarketedlabelingforNDA017608ICUMedicalIncDEXTROSE5%ANDLACTATEDRINGER'SINPLASTICCONTAINER-packageinsert,container(bag)labelandoverwrapbaglabel.
","Closed""2020-2074","03/06/2020","AmericanOversight","FINALTALKINGPOINTSORBACKGROUNDMATERIALSPREPAREDFORANYCONGRESSIONALBRIEFINGSORHEARINGSORPRESSENGAGEMENTSBYAGNECYLEADERSHIPREGARDINGTHEONGOINGCORONAVIRUSOUTBREAK","AcknowledgementLetter""2020-2075","03/06/2020","RegistrarCorp","Werequestaspreadsheetlistingthe23publiclyavailabledatapointsforallNoticesofFDAActionissuedduringthetimeframebetweenFebruary1,2020andFebruary29,2020,inthesameformatasourpreviousFOIArequest2018-9765.
","Closed""2020-2076","03/06/2020","RegistrarCorp","EnforcementReports","AcknowledgementLetter""2020-2077","03/06/2020","FDAZILLA","Pleaseprovidethefollowing1inspection-relateddocumentsinelectronicPDFformat:The483(inelectronicformat)forFoods&CosmeticsinspectionofKrispyKremeDonutCoIncending11/15/2019atthelocationinLouisvilleKY,UnitedStates.
Pleasesenddocumentsasemailattachments.
","Closed""2020-2078","03/06/2020","THEWALLSTREETJOURNAL","INTEGRATEDDNATECHNOLOGIES,CORALVILLE,IA-483S","NoRecord(s)""2020-2079","03/06/2020","FDAZILLA","The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending06/28/2000atthelocationinBostonMA,UnitedStates.
The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending01/18/2002atthelocationinBostonMA,UnitedStates.
The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending09/29/2006atthelocationinBostonMA,UnitedStates.
The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending09/12/2008atthelocationinBostonMA,UnitedStates.
The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending07/21/2010atthelocationinBostonMA,UnitedStates.
The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending05/24/2012atthelocationinBostonMA,UnitedStates.
Pleasesenddocumentsasemailattachments.
","Closed""2020-2080","03/06/2020","MeganSchnur","SearchingCVM'sADEdatabaseforadverseeventsinUSassociatedwithtulathromycininallspeciesforMarch2018throughFebruary2019.
CVMADEComprehensiveClinicalDetailReportListingfortulathromycinfromMarch2018throughFebruary2019.
","AcknowledgementLetter""2020-2081","03/06/2020","RegistrarCorp","WerequestaspreadsheetidentifyingthenameandcontactinformationrelatedtoeachDrugMasterFile(DMF)OriginalSubmissionfromJanuary1,1973,toDecember31,1973","Closed""2020-2082","03/06/2020","FDAZILLA","The483(inelectronicformat)forBiologicsinspectionofBioconnectionBVending06/01/2018atthelocationinOss,Netherlands.
TheEIR(inelectronicformat)forBiologicsinspectionofBioconnectionBVending06/01/2018atthelocationinOss,Netherlands.
","AcknowledgementLetter""2020-2083","03/06/2020","RegistrarCorp","WerequestaspreadsheetidentifyingthefirmsthatreceivedFDAWarningLettersbetweenOctober1,2011,andFebruary29,2020","Closed""2020-2084","03/06/2020","GailRichards","WewouldliketoreviewthefileassociatedwithIHCTOALetterDoc.
SPJ1600031","NotReasonablyDescribed""2020-2085","03/06/2020","TheWeinbergGroup","HumanadverseeventdrugMedWatchreportsforthefollowingCaseIDs:158234221687657116882412168824131688243316882434169274111695439917022084170220901710513517166815","Closed""2020-2086","03/06/2020","LUIPINPHARMACEUTICALSINC","DUREZOLNDA22-212/S015-RVWSUMMARIES,APRVLLTR","Closed""2020-2087","03/06/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofSmith&NephewOrthopaedicsLtd.
(Aurora)ending05/15/2014atthelocationinLeamingtonSpa,UnitedKingdom.
TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofSmith&NephewMedical(Suzhou)Limitedending07/09/2014atthelocationinSuzhou,China.
","AcknowledgementLetter""2020-2088","03/06/2020","MidAmericaPharmaceuticals","DrugMasterFilesofANDAA070730,thereferencestandardoftriamcinoloneacetonidedentalpastemanufacturedbyTaroPharmaceuticalsUSAInc.
","WithdrawnClosedw/oCharges""2020-2089","03/06/2020","FOIServices,Inc.
","63VAERScasereportsregardingGardasil.
","AcknowledgementLetter""2020-2090","03/06/2020","MotherwayandNapleton","TranscriptofJanuary29th,2009JointmeetingoftheAnestheticandLifeSupportDrugsAdvisoryCommitteeonpropoxyphene.
Specifically,thestatementofconflictmadeatthebeginningofthemeeting.
","Closed""2020-2091","03/06/2020","LachmanConsultants","MostrecentUSpackageinsertforNDA16363approvedattimeofproductdiscontinuation.
","AcknowledgementLetter""2020-2092","03/06/2020","Xproassociates,LLC","483issuedto"JapanFoodResearchLabs";Chitose,Japan;OnCDERinspection;MynotethismyfirstrequestinMarch2020(191108km-1)","Closed""2020-2093","03/06/2020","RegistrarCorp","spreadsheetlistingthe23publiclyavailabledatapointsforallsystemMayProceedsandERMayProceedsissuedduringthetimeframebetweenFebruary1,2020throughFebruary29,2020","AcknowledgementLetter""2020-2094","03/06/2020","LianeHogan","AllapprovedandmarketedINDfilingforthedrugCARBAGLU(carglumicacid)producedbyRecordatiRareDiseasesInc.
","WithdrawnClosedw/oCharges""2020-2095","03/06/2020","BROWNCHIARILLP","Alldocumentssubmittedaspartofthe510(k)applicationforK041697.
","AcknowledgementLetter""2020-2096","03/06/2020","ZydusPharmaceuticals(USA)Inc.
","PleaseprovidesummarybasisofapprovalforActigallCapsules150mgand300mgfortheapplicantAllergan-N019594","Closed""2020-2097","03/06/2020","ZydusPharmaceuticals(USA)Inc.
","PleaseprovideSummarybasisofApprovalforPURINETHOL(mercaptopurine)tablets50mgfortheapplicantStasonPharmaceuticalsInc-N009053","Closed""2020-2098","03/06/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofVanderbiltUniversityMedicalCenterRDRCending04/01/2015atthelocationinNashvilleTN,UnitedStates.
","AcknowledgementLetter""2020-2099","03/06/2020","FDAZILLA","TheEIR(inelectronicformat)forBiologicsinspectionofHemaCareCorporation/CoralBloodServices,Inc.
ending06/27/2003atthelocationinCambridgeMA,UnitedStates.
TheResponse(inelectronicformat)forBiologicsinspectionofHemaCareCorporation/CoralBloodServices,Inc.
ending06/27/2003atthelocationinCambridgeMA,UnitedStates.
The483(inelectronicformat)forBiologicsinspectionofMassBiologicsending11/19/2019atthelocationinBostonMA,UnitedStates.
Pleasesenddocumentsasemailattachments.
","Closed""2020-2100","03/06/2020","CohenMilsteinSellers&TollPLLC","2016-6351","Closed""2020-2101","03/06/2020","CohenMilsteinSellers&TollPLLC","RANBAXYLABS-INVESTIGATION","Closed""2020-2102","03/09/2020","UnitedExchangeCorp.
","WarningLetter/ImportAlert79-01LetterforthebelowfactoryZhejiangHongyuMedicalCommodityCo.
,Ltd.
(registrationnumber3005083505)No.
668ChanHuaRoadFotangTownIndustrialFunctionalArea,ZhejiangCNDatePublished:11/02/201580F--QMBandage,ElasticDesc:Bandages","AcknowledgementLetter""2020-2103","03/09/2020","Kohl,Harris,Nolan,&McCarthyP.
C.
","WarninglettersissuedtoWildBill'sTobacco,MI","Closed""2020-2104","03/09/2020","FaegreDrinkerBiddle&ReathLLP","allinvestigationmaterialsrelatedtoanyandallCyclosporarecallsforalldomesticallygrownproductsthatweregrownandharvestedwithinthelastfiveyears.
Wearespecificallyrequestingalltracebackandsupplychaininformation,includingdistributorandsupplierinformation,aswellasallpotentialsourcesofthecontaminations,includingtheproductsandregions/statesthatwereimplicated.
","WithdrawnClosedw/oCharges""2020-2105","03/09/2020","JohnLBurnett","1.
Irequestalldocumentscomprising,stating,reflecting,orthatwereusedorrelieduponin,theinvestigationanddecision-makinganddecisionrelatingtothedecisionstatedintheOctober29,2019,memorandumfromFDANCTRIACUCChairMarkHartetc","AcknowledgementLetter""2020-2106","03/09/2020","RoyL.
Jacobs","RecordsrelatingtoPenafielSpringWaterandArseniccontamination;ImportAlertsonPenafiel;ImportAlertonflavoredwater;treatmentforPenafielSpringWater","AcknowledgementLetter""2020-2107","03/09/2020","Washington&Company","Title:LEADERSHIPDEVELOPMENTTEAMTRAININGContractNumber:75F40119K90077PeriodofPerformance:09/26/2019to10/30/2019ContractOfficer:HHSARALPHTitle:OPEQLEADERSHIPTEAMDEVELOPMENTANDTRAININGContractNumber:75F40119C10066PeriodofPerformance:08/20/2019to11/15/2019ContractOfficer:HHSKSMITH","PendingAction""2020-2108","03/09/2020","FDAZILLA","TheEIR(inelectronicformat)forHumanDrugsinspectionofKoren,MichaelJ.
,MDending02/02/2015atthelocationinJacksonvilleFL,UnitedStates.
TheResponse(inelectronicformat)forHumanDrugsinspectionofKoren,MichaelJ.
,MDending02/02/2015atthelocationinJacksonvilleFL,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofKlockeofAmericaending04/27/2016atthelocationinFortMyersFL,UnitedStates.
TheResponse(inelectronicformat)forHumanDrugsinspectionofFormulatedSolutions,LLCending02/11/2010atthelocationinLargoFL,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofBausch&Lombending05/26/2017atthelocationinTampaFL,UnitedStates.
","AcknowledgementLetter""2020-2109","03/09/2020","ORGANOCORPORATION","Form483relatedtopharmaceuticalwaterandpharmaceuticalwatersystems","NotReasonablyDescribed""2020-2110","03/09/2020","Genentech,Inc.
","EntireredactedSBAforXeljanz(tofacitinibcitrate),NDA203214/S-018,fortheindicationofmoderatelytoseverelyactiveulcerativecolitis(UC),approvedMay30,2018.
EntireredactedSBAforStelara(ustekinumab),BLA125261/S-152,fortheindicationoftreatmentofadultswithmoderatelytoseverelyactiveulcerativecolitis,approvedOctober18,2019.
","AcknowledgementLetter""2020-2111","03/09/2020","WinterlightLabs","Thepre-submissiondocument(alsocalledQ-submission)for:DeviceName:CANTABMobile,Submittedby:CambridgeCognition,510(k)Number:K161328,ProductCode:PKQ","AcknowledgementLetter""2020-2112","03/09/2020","KevinMeyer","Lookingforthe"74-dayletter"issuedinresponsetotheformalNDAsubmissionfordrugcommerciallynamed'Qtrypta'perZosanoPharmaCorporation.
TheNDAwassubmittedFriday20th,2019.
Thisdocumentconfirmsanactiondate,confirmsstandardversuspriorityreview,andidentifiesanypreliminarydeficienciesinthenewdrugapplication.
","ClosedDenial""2020-2113","03/09/2020","ENVIRONMENTALWORKINGGROUP","Adverseeventreportsrelatedtoformaldehydehairstraightenersandcommunicationsrelatedtoformaldehydeinhairstraighteners.
","AcknowledgementLetter""2020-2114","03/09/2020","CiplaLimited","PleaseprovideredactedcopyofUSFDA483SHILPAMEDICARELIMITED,PlotNo.
S-20toS-26,GreenIndustrialPark,Polepally(V),Jadcherla(M),MahaboobnagarDist.
,Telangana-509301DateofInspection:13thFebto25thFeb2020.
Document:redactedcopyof483issuedtoorganization","Closed""2020-2115","03/09/2020","FDAZILLA","The483(inelectronicformat)forFoods&CosmeticsinspectionofTheZinneken'SGroupLlcending11/22/2019atthelocationinCambridgeMA,UnitedStates.
The483(inelectronicformat)forFoods&CosmeticsinspectionofWildfish,LLCending02/21/2020atthelocationinBostonMA,UnitedStates.
","Closed""2020-2116","03/09/2020","PhibroAnimalHealthCorporation","AnalyticalMethod2.
NicarbazinChickenlivertissueresiduesofDNCweremeasuredusingavalidatedLC-MS/MSmethod.
ThismethodisonfileattheCenterforVeterinaryMedicine.
","AcknowledgementLetter""2020-2117","03/09/2020","JoanZenzen","75-N-0303FDADockets:75-A-019078-N-086576-N-009577-P-039377-P-0388","WithdrawnClosedw/oCharges""2020-2118","03/09/2020","SkinBiology","microbiologyanalyticalresultsforSample#1100220basedoncosmeticproductscollectedfromFirm#1000208498on10FEB2020(receivedatFDAfacilityon11FEB2020accordingtocorrespondencewithFDAinvestigator)","Closed""2020-2119","03/09/2020","ZydusPharmaceuticals(USA)Inc.
","SummarybasisofApprovalforSINEMET(carbidopalevodopa)Tablets(10mg;100mg,25mg;100mg,25mg;250mg)forapplicantMERCKSHARPANDDOHMECORP-N017555.
","Closed""2020-2120","03/09/2020","InternationalTradeToday","IdentityofanyapplicantsforparticipationintheVoluntaryQualifiedImporterProgramfortheFY2020andFY2021participationperiods,respectively.
Pleaselistnamesofcompaniesandcontactsprovided.
PleaselistseparatelyforapplicationsreceivedforFY2020andFY2021periods.
","AcknowledgementLetter""2020-2121","03/09/2020","FOIServices,Inc.
","ListofFDAinspections1/1/2010-present.
Pleaseseeattached.
","AcknowledgementLetter""2020-2122","03/09/2020","WillKent","InvestigationandrulingagainstUltimateFXoperatingLasershowswithoutanapprovedVariancefromtheCDRH","Closed(Fee-related)""2020-2123","03/09/2020","FOIServices,Inc.
","Parexel,BillericaMA08/2019inspectioninformation.
","AcknowledgementLetter""2020-2124","03/09/2020","ORGANOCORPORATION","IwanttoknowthecontentsofFrom483onpharmaceuticalwaterandpharmaceuticalwatersystems.
QualificationandsubsequentControlmethods(samplingpoints,samplingmethods),etc.
","NotReasonablyDescribed""2020-2125","03/09/2020","InternationalTradeToday","NumberofapplicationsFDAhasreceivedtoparticipateintheVoluntaryQualifiedImporterProgramfortheFY2020andFY2021applicationperiods,respectively.
PleasedistinguishbetweenthenumberofFY2020andFY2021applications.
","Closed""2020-2126","03/09/2020","FOIServices,Inc.
","N211733approvalinformation,AdvilDualAction","AcknowledgementLetter""2020-2127","03/09/2020","MerieuxNutriSciences","WewouldlikeanExcelfileofalltheFDAFoodRecalldataforthelast15years.
","AcknowledgementLetter""2020-2128","03/09/2020","WillKent","InvestigationandrulingagainstLiveEntertainmentChicagooperatingLasershowswithoutanapprovedVariancefromtheCDRH","Closed(Fee-related)""2020-2129","03/09/2020","TheraVetUSA","NADA012-204NADA012-198NADA123-815NADA30-414","AcknowledgementLetter""2020-2130","03/09/2020","BioLifePlasmaServicesL.
P.
","RequestingEstablishmentInspectionReportforJune2018inspectionof:FEI1000221914BioLifePlasmaServiceL.
P.
2197ParkwayLakeDriveHoover,AL35244","Closed""2020-2131","03/09/2020","MylanLaboratoriesLimited,India","SummaryBasisofApprovalforERYTHROCIN(erythromycinlactobionateforinjection,USP)Strength:EQ500MGBASE/VIALandEQ1GMBASE/VIALApplicationNumber:N050609ApplicantHolderFullName:HOSPIRAINCApprovalDate:Sep24,1986","Closed""2020-2132","03/09/2020","KapstoneMedical","PMAsummaryforP900009","Closed(Fee-related)""2020-2133","03/09/2020","TevaPharmaceuticals","CMC(Chemistry,ManufacturingandControls)sectionsforSupplements1through6forEyevance'sZerviateN208694.
","WithdrawnClosedw/oCharges""2020-2134","03/09/2020","AkathisiaAlliance","ReportsofakathisiafromSSRIantidepressants*inthelast5years.
*includingall:citalopram(Celexa),escitalopram(Lexapro),fluoxetine(Prozac),fluvoxamine(Luvox),fluvoxamineCR(LuvoxCR),paroxetine(Paxil),paroxetineCR(PaxilCR),sertraline(Zoloft)","Closed""2020-2135","03/09/2020","BlockImagingParts&Service","COR19000472","AcknowledgementLetter""2020-2136","03/09/2020","WINSTON&STRAWNLLP","AllrecordsmaintainedbytheFoodandDrugAdministration("FDA")relatingtoalldisclosabledocuments/communicationsregardingtheVascepasNDA(NDA202057/S-035),including,butnotlimitedtoanyandallapplications,supplements,briefingdocuments,meetingminutes,approvals,correspondence,andrelatedpatentinformation.
","AcknowledgementLetter""2020-2137","03/09/2020","WendyTrotta","allincidentsandreportsforSerestofleacollars","WithdrawnClosedw/oCharges""2020-2138","03/09/2020","ChristopherGaspar","K191016","AcknowledgementLetter""2020-2139","03/09/2020","RelishLabsLLCd/b/aHomeChef","InformationregardingentriesforwhichRelishLabsLLCorHomeChefwasdeclaredastheimportersubjecttotheUSFDA'sForeignSupplierVerificationProgramsforFoodImporters(FSVP)regulation(21CFRpart1subpartL,sections1.
500–1.
514).
","AcknowledgementLetter""2020-2140","03/09/2020","CARATherapeutics","EstablishmentInspectionReport(EIR)anfFDAform483forinspectionenddate6/21/2019conductedbyFDAORAatJiangsuBaozong&BaodaPharmachrmCo.
,LTD.
,No.
!
0YuejiangRoad,ChangjiangTown,Rugao,Jiangsu,China","WithdrawnClosedw/oCharges""2020-2141","03/09/2020","HOGANLOVELLSUSLLP","IherebyrequestalldocumentsrelatedtotheFebruary13,2020recallofGourmetInternationalandButlersChocolatesUCrecallofIrishWhiskeyDarkChocolate3.
5OZTabletBarduettoundeclaredmilk.
","PartialResponse""2020-2142","03/09/2020","BarbaraLePetri","summarybasisofapprovalforthecardiovascularindicationforJardiance.
","WithdrawnClosedw/oCharges""2020-2143","03/10/2020","SushmaSubramanian","Irequestalistofeveryinspectionsatartisancheesefacilityinthepastfiveyears,aswellastheoverallnumberofinspectionsofthetop20foodproducersintheUnitedStatesinthepastfiveyears.
IalsorequestanyandallemailswrittenbyMonicaMetzregardingartisancheesemakersfromthepastfiveyears.
","AcknowledgementLetter""2020-2144","03/10/2020","Spence","PursuanttotheFreedomofInformationAct,5U.
S.
C.
§552,wewishtoobtainarecordofthecalendarsofWilliamDunn,theU.
S.
FoodandDrugAdministration'sDirectoroftheDivisionofNeurologyProducts(DNP),fortheentiretyofJanuary2020.
AllconferencesandmeetingsMr.
Dunnattendedoverthedescribedperiodoftimeweaskbedisclosed,aswellasanycalendarinvitationsrequestedofhim.
","AcknowledgementLetter""2020-2145","03/10/2020","LeonardSorgi","FAERSREPORTS","Closed""2020-2146","03/10/2020","TERUMOMEDICALCORP","PleasesendallFDA483lettersforAdvocateHealthlocatedinOakbrookTerrace,IL.
","WithdrawnClosedw/oCharges""2020-2147","03/10/2020","McKeeVoorhees&Sease","Recordsofanyaudits,warningletters,orenforcementactionsrelatedtoGoldmanPharmaceuticalGroupandFish-Aidantibiotics,andanyinternalFDAcorrespondencerelatedtopotentialenforcementactions.
","NotReasonablyDescribed""2020-2148","03/10/2020","McKeeVoorhees&Sease","Recordsofanyapplicationsfordrugapprovaland/orindexingfornon-foodanimalsunderMUMSofactiveingredientswhichareantimicrobialsthatareapprovedashumanantibiotics.
Also,internalFDAcorrespondenceordocumentsregardingwhetherantimicrobialswouldbeeligibleforindexing.
","AcknowledgementLetter""2020-2149","03/10/2020","LoseyPLLC","Allelectroniccommunications,including,butnotlimitedto,emails,SMStextmessage,MMScommunications,andinstantmessagesconcerningCytocomfromJanuary1,2013throughDecember31,2018.
Allelectroniccommunications,including,butnotlimitedto,emails,SMStextmessage,MMScommunications,andinstantmessagesconcerningImmuneTherapeuticsfromJanuary1,2013throughDecember31,2018.
etc","Closed(Fee-related)""2020-2150","03/10/2020","OrientalInspirationLimited","K032612FIRSTPARTY","AcknowledgementLetter""2020-2151","03/10/2020","LauraMeyerGregory,Esq.
","PleaseconsiderthisletteraformalrequestpursuanttotheFreedomofInformationAct,5U.
S.
C.
§552etseqforallpublicrecordspertainingtoGoldStarSmokedFish,570SmithStreet,Brooklyn,NewYork,11231,and/orGalinaPincowandRobertPincow,fromJanuary1,2017tothepresent.
","AcknowledgementLetter""2020-2152","03/10/2020","DrAjayPhadke","Form483forDrReddysMiryalagudaPlant3","Closed""2020-2153","03/10/2020","GailRichards","Weareseekingacopyoftheinquiry(s)thatresultedintheattached"ItHasCometoOurAttentionLetter"DocumentNo.
SPJ1600031.
","AcknowledgementLetter""2020-2154","03/10/2020","HymanPhelps&McNamaraP.
C.
","Allrecordspertainingtotheuseorproposeduseofbioactivesubstancesmilkfatglobulemembrane(MFGM)ininfantformulathataremaintainedbytheCenterforFoodSafetyandAppliedNutrition,includinganysuchrecordsmaintainedbytheOfficeofFoodAdditiveSafetyand/ortheInfantFormulaandMedicalFoodsStaff.
","AcknowledgementLetter""2020-2155","03/10/2020","TheHartfordInsuranceSpecialInvestigationsUnit","AnyFDAwarninglettersorinspectionreports(EIR)onfileastheypertaintoBiondillo'sBakingCompany,a.
k.
a.
Biondillo'sToday'sTemptations,a.
k.
a.
Biondillo'sorToday'sTemptations,locatedat4900W.
Division,Chicago,IL60651.
","Closed(Fee-related)""2020-2156","03/10/2020","FDAZILLA","The483(inelectronicformat)forBiologicsinspectionofHemaCareBioScienceending04/28/2006atthelocationinFtLauderdaleFL,UnitedStates.
","Closed""2020-2157","03/10/2020","ShawsMarkets","AllFDArecordsinconnectionwiththeShawsMarketsTobaccoRetailerInspectionReferenceNumber20VT043150(includingIDusedbyminor)","AcknowledgementLetter""2020-2158","03/10/2020","FDAZILLA","Pleaseprovidethefollowing1inspection-relateddocumentsinelectronicPDFformat:The483(inelectronicformat)forBiologicsinspectionofNAMSAending06/11/2014atthelocationinChasseSurRhone,France.
Pleasesenddocumentsasemailattachments.
","AcknowledgementLetter""2020-2159","03/10/2020","FXMResearchCorp.
","NeedunredactedEstablishmentInspectionReport(EIR)forHectorWiltz,MD.
FEI:3007050448.
EIStartdate:11/25/2019EIEnddate:12/05/2019Thisreporthas15pagesanditwasgeneratedandsignedbyFDAInvestigatorRichardA.
Lighton12/30/2019","AcknowledgementLetter""2020-2160","03/10/2020","MaryPendergastDBAPendergastConsulting","documentsprovidedinthepublishedsummarybasesforapproval(SBAs)forthe(1)originalpembrolizumabapprovalon9/4/14,(2)thesupplementfortumoragnosticmicrosatelliteinstability/differentmismatchedrepair(Supp-14)approvedon5/23/17,and(3)thesupplementforgastricorgastrointestinalcancer(Supp-24)approvedon9/27/17.
","AcknowledgementLetter""2020-2161","03/10/2020","MayerBrezis","adverseeventreport12375457","Closed""2020-2162","03/10/2020","NomuraFinancialAdvisory&Securities(India)PrivateLimited","NeedForm483with3(Three)observationsissuedtoDr.
Reddy'sAPIManufacturingPlant-5atMiryalaguda,NalgondaDistrict,Telangana,bytheUSFDAfortheinspectioncompletedinMarch2020.
","Closed""2020-2163","03/10/2020","CapellaUniversity","FiveyearsworthofmedicaldeviceForm483data","NotReasonablyDescribed""2020-2164","03/10/2020","LeonardSorgi","FAERSRECS","WithdrawnClosedw/oCharges""2020-2165","03/10/2020","Princessed'IsenbourgetCie","CMPLNT157444","AcknowledgementLetter""2020-2166","03/10/2020","LINDA'SGOURMETLATKES","LINDA'SGOURMENTLATKES,VANNUYS,CA-EIR6/26/19","AcknowledgementLetter""2020-2167","03/10/2020","JANETGETTER","LEVAQUIN-RPT","Closed""2020-2168","03/10/2020","AltriaClientServices","PHILIPMORRISUSAINC-SUBSTANTIALEQUIVALENCERPTSE0015606","Closed""2020-2169","03/10/2020","AltriaClientServices","USSMOKELESSTOBACCOCOMPANYCO-SUBSTANTIALEQUIVALENCERPTSE0015402","Closed""2020-2170","03/10/2020","RegistrarCorp","SantaHelenaIndustriadeAlimentosS/AshippingdocumentsrelatedtotheshipmentthatwasrefusedentryonOctober7,2019withentrynumberEntryDP4-8291668-2/21/5/,including,butnotlimitedto:NoticesofFDAAction,productlabels,shippername,consigneename,containernumber.
","AcknowledgementLetter""2020-2171","03/10/2020","AltriaClientServices","USSMOKELESSTOBACCOCOMPANYCO-SUBSTANTIALEQUIVALENCERPTSE0015469","Closed""2020-2172","03/10/2020","PaskowitzLawFirmP.
C.
","1.
AlldocumentsconcerninglevelsofarsenicinStarkeyWater(bottledwaterbrand)2.
AlldocumentsconcerningarecallofStarkeyWaterduetoarseniclevelsin2016-2017","AcknowledgementLetter""2020-2173","03/10/2020","TIMEMAGAZINE","AnyemailcorrespondencebetweenJuulLabsCEOKevinBurnsandtheFDACommissioner'sofficebetweenandincludingSeptember1andSeptember30,2018.
","AcknowledgementLetter""2020-2174","03/10/2020","TIMEMAGAZINE","AnydocumentsorrecordsrelatedtoJuulLabsInc.
generatedorobtainedduringtheSeptember24-28,2018FDAinspectionofJuul'sheadquartersat56020thStreet,SanFrancisco.
","PartialResponse""2020-2175","03/10/2020","Cole,Scott,&Kissane,PA","inspections,inspectionreports,tracebackdate,epidemiologicdata,foodandenvironmentaltestingdateregarding"SigaLogisticsdeRLdeCVofMorelos,Mexico"concerningbasilimportedbySigaLogistics,SigaLogisticsVoluntaryRecallofbasil,andthe2019Cyclosporacayetanensislinkedtobasilfortheperiod:January1,2019toDecember1,2019.
","Closed""2020-2176","03/10/2020","QuinlanPartners","Allrecordsandcorrespondenceregardinganyofthefollowingcompanies:CosmoPharmaceuticals,AriesPharmaceuticals,andCassiopeaSpA,includingrecordsrelatedtocomplaintsandinvestigationsaswellasapprovalsand/ordenialsofdrugandmedicaldeviceapplications.
","NotReasonablyDescribed""2020-2177","03/10/2020","UserWiseConsulting","IwouldlikethemostrecentlysubmittedNDAand/orBLAforatransferdevicethatinvolveslyophilizedinjectionsandisintendedforusebylayusers.
Itisnotimportantwhetherthesubmissionwasrejectedornot.
","NotReasonablyDescribed""2020-2178","03/10/2020","PointeastPharmaConsultingLLC","Peptavlon(Ayerst)NDA","Closed""2020-2179","03/10/2020","FOIServices,Inc.
","MedWatchReportsforSteglatro,Januvia,Keytruda,etc.
Pleaseseeattached.
","WithdrawnClosedw/oCharges""2020-2180","03/10/2020","SCHLICHTERBOGARD&DENTONLLP","GREENBRIERINTERNATIONALINC,CHESAPEAKE,VA1/14-18/19;BICOOYACOSMETICSLTD8/11/17;NINGBOPULSIDAILYCHEMICALPRODUCTSCO8/13/19,ETC-483S","Closed""2020-2181","03/10/2020","DEFIBTECHLLC","K173553","AcknowledgementLetter""2020-2182","03/10/2020","AdvinBiotechInc","K001976decisionsummaryorsummary,andpackageinsertrecord.
","AcknowledgementLetter""2020-2183","03/10/2020","Dr.
Reddy'sLabooratoriesInc","CompleteSummaryBasisofApproval(SBOA)andFDAFinalReviewsoftheOriginalNDA,INDERAL(PropranololHydrochlorideTablet),NDA#016418approvedonOct18,1982.
","Closed""2020-2184","03/10/2020","FOIServices,Inc.
","K191313,UnitySubcutaneousDeliverySystemforRemodulinbyDEKA.
","AcknowledgementLetter""2020-2185","03/10/2020","FOIServices,Inc.
","NDA208193,Ozobaxapprovalinformation","AcknowledgementLetter""2020-2186","03/10/2020","SEEGERWEISSLLP","1.
FDAForm483,ActavisLaboratoriesFL,Inc.
,(July19,2018)2.
FDAForm483,TevaAPIIndiaPvt.
Ltd.
,(April16,2019)","Closed""2020-2187","03/10/2020","BEVERIDGE&DIAMOND","reportofallFOIArequestsfiledwithFDA'sCenterforFoodSafetyandAppliedNutrition("CFSAN"),includingrelatedoffices,fromJanuary1,2020throughFebruary29,2020","Closed""2020-2188","03/10/2020","ZydusPharmaceuticals(USA)Inc.
","PleaseprovideSummarybasisofapprovalforSALIX(FUROSEMIDE)TABLETS(Eachtabletcontains12.
5or50milligramsfurosemide.
)forapplicantIntervet,Inc.
(NADA:N34621)","Closed""2020-2189","03/10/2020","FOIServices,Inc.
","Correctedrequestfor6230722,regardingMedWatchreportsforSteglatro,Belsomra,etc.
","AcknowledgementLetter""2020-2190","03/11/2020","THENEWYORKTIMES","namesofdrugsordrugingredientsthattheFDAiswatchingforsignsofacoronavirus-relatedshortage","AcknowledgementLetter""2020-2191","03/11/2020","FDAZILLA","2019-11570,2019-11566,2019-11564,2019-11560,2019-11531","Closed""2020-2192","03/11/2020","FDAZILLA","2019-11833,2019-11836,2019-11634,2019-11642,2019-11621","Closed""2020-2193","03/11/2020","DhanvantariAIIndiaPvtLtd","2019-63262019-63342019-66142019-66102019-6613","Closed""2020-2194","03/11/2020","DhanvantariAIIndiaPvtLtd","2019-59392019-59092019-59082019-59342019-6335","Closed""2020-2195","03/11/2020","FDAZILLA","2019-12013,2019-11895,2019-11851,2019-11838,2019-11829.
","Closed""2020-2196","03/11/2020","FDAZILLA","2019-11533,2019-11532,2019-11510,2019-11509,2019-11508.
","Closed""2020-2197","03/11/2020","DhanAI","2020-1169","Closed""2020-2198","03/11/2020","FOIServices,Inc.
","2019-110,2018-7199,2018-4113,2019-5049,2018-8567.
","Closed""2020-2199","03/11/2020","FOIServices,Inc.
","2019-581,2018-2874,2018-3945,2018-2250,2018-770.
","Closed""2020-2200","03/11/2020","Cole,Scott,andKissane,PA","allrecordsregarding"LaLagunaHerbsSAS"concerningbasilimportedbyLaLagunaHerbs,ImportAlert99-35withregardingtoLaLagunaHerbs,anydocumentsshowingbasiltestedforCyclosporacayetanensisfromLaLagunaHerbsfortheperiod:January1,2019toDecember1,2019.
","AcknowledgementLetter""2020-2201","03/11/2020","FOIServices,Inc.
","2018-7181,2018-3541,2018-9188,2018-34552018-8722.
","Closed""2020-2202","03/11/2020","FOIServices,Inc.
","2018-8045,2018-242,2018-244,2018-2225,2018-9131.
","Closed""2020-2203","03/11/2020","FDAZILLA","TheEIR(inelectronicformat)forHumanDrugsinspectionofSharpBethlehemLLCending08/27/2015atthelocationinBethlehemPA,UnitedStates.
etc","AcknowledgementLetter""2020-2204","03/11/2020","DhanvantariAIIndiaPvtLtd","2020-12552020-15252020-15262020-15282020-1529","Closed""2020-2205","03/11/2020","TechnotherapyPublicBenefitCorp","Thisistorequest:1)All510(k)s,IDEs,PMAsandotherdevice-relatedsubmissionsforallproductscorrespondingtoclassification882.
5801ComputerizedBehavioralTherapyDeviceForPsychiatricDisorders,andallrelease-ableelectronicorpapercorrespondenceorotherdocumentationreceivedfromsubmittingparties.
","AcknowledgementLetter""2020-2206","03/11/2020","King&SpaldingLLP","DataandinformationrelatedtoFDA'sapprovalofEluryng(etonogestrelandethinylestradiol)vaginalring(ANDA210380)onDecember11,2019,includingthedataandinformationdescribedin21C.
F.
R.
§314.
430(e)-(f).
","AcknowledgementLetter""2020-2207","03/11/2020","Therapeutics,Inc.
","Item1(i.
e.
,TheTableofContents/Index)oftheApplicant's(EliLilly'sandCo.
)NewDrugApplicationforNDA18-250(Tradename:Oraflex,benoxaprofen).
Forreference,theNDA(whichincludestheINDEXpagesweareseeking)wassubmittedon1/17/1980andreceivedbyFDAon1/23/1980.
Atthistime,weareonlyrequestingtheINDEXpages(item1)oftheApplicant'sNDA.
","AcknowledgementLetter""2020-2208","03/11/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofJohnGabriel,MDending10/22/2013atthelocationinNorthRichlandHillsTX,UnitedStates.
TheResponse(inelectronicformat)forHumanDrugsinspectionofJohnGabriel,MDending10/22/2013atthelocationinNorthRichlandHillsTX,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofAlconResearchLLCending05/23/2016atthelocationinFortWorthTX,UnitedStates.
Pleasesenddocumentsasemailattachments.
","AcknowledgementLetter""2020-2209","03/11/2020","DhanvantariAIIndiaPvtLtd","2020-10142020-10152020-11782020-12532020-1254","Closed""2020-2210","03/11/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofICUMedicaldeMexico,S.
A.
deC.
V.
ending02/18/2016atthelocationinEjidoManeadero,Mexico.
TheResponse(inelectronicformat)forMedicalDevices&RadHealthinspectionofICUMedicaldeMexico,S.
A.
deC.
V.
ending02/18/2016atthelocationinEjidoManeadero,Mexico.
","AcknowledgementLetter""2020-2211","03/11/2020","BLOOMBERGNEWS","listofanyinspectionsofAlternativeIngredientsandFlexbetweenJan.
1,2019toMarch3,2020","Closed""2020-2212","03/11/2020","CONSUMERREPORTS","2020-1328,2020-746,2020-782","Closed""2020-2213","03/11/2020","Hyman,Phelps&McNamaraP.
C.
","Allrecordspertainingtotheuseorproposeduseofbioactivesubstancesmilkfatglobulemembrane(MFGM)ininfantformulathataremaintainedbytheCenterforFoodSafetyandAppliedNutrition,includinganysuchrecordsmaintainedbytheOfficeofFoodAdditiveSafetyand/ortheInfantFormulaandMedicalFoodsStaff.
","DuplicateRequest""2020-2214","03/11/2020","FDAQuality&RegulatoryConsultantsLLC","DearFOIteam,IwouldseeklistofsuppliersforbelowmentionedentitiesinspectedbyFDACBERandCDERdivisionforlast5years1.
Clinicalsinvestigatorsites2.
Contractresearchorganizations3.
Bioanalyticallaboratories4.
Drugmanufacturers","NotReasonablyDescribed""2020-2215","03/11/2020","TheGoodFoodInstitute","Allrecordsthatdiscusstheuseofseafoodtermsonlabelsofplant-basedproductsandallrecordsrelatedtotheFebruary19,2020"SeafoodSafetyIssuesofMutualInterest"meeting.
","AcknowledgementLetter""2020-2216","03/11/2020","TheRecord,Inc.
","allemailsbetweenFDAstaffandemailaddressesfromthefollowingdomainsfromJan.
1,2015tothepresent:-beasleyallen.
com-sgptrial.
com-LanierLawFirm.
com-weitzlux.
com-nsprlaw.
com-napolilaw.
com-simmonsfirm.
com-lawpga.
com-angeloslaw.
com-motleyrice.
com","NotReasonablyDescribed""2020-2217","03/11/2020","FOIServices,Inc.
","K090130","AcknowledgementLetter""2020-2218","03/11/2020","FXMClinicalResearchMiramar,LLC.
","NeedunredactedEstablishmentInspectionReport(EIR)forFranciscoFlores,MD.
FEI:3011630509.
EIStartdate:11/12/2019EIEnddate:11/19/2019Thisreporthas13pagesanditwasgeneratedandsignedbyFDAInvestigatorAngelicaM.
Chicaon12/03/2019","PartialDenial""2020-2219","03/11/2020","Imagenix,Inc.
","DEN170072-FDAdeNovosubmission(lessappropriateredactions)forTimpelEnlight1810","AcknowledgementLetter""2020-2220","03/11/2020","MedicalCollegeofWisconsinDepartmentofAnesthesiology","AnyandallinformationregardingselectedadverseeventreportsinvolvingthedrugSugammadex/Bridion.
","AcknowledgementLetter""2020-2221","03/11/2020","UPMPHARMACEUTICALS","MylanPharmaceuticalsInc.
,ChesnutRidgeRDMorgantownWVfacility,483givenon11/18/16","Closed(Fee-related)""2020-2222","03/11/2020","TexasPublicHealthSolutionsLLC","IamsearchingforthemostrecentFoodFacilityRegistrationfortheAmazonFreshFulfillmentWarehouselocatedat940W.
BethelRoad,Coppell,TX75019.
","ClosedDenial""2020-2223","03/11/2020","LAWOFFICESOFJOSEPHPBERGLUNDPC","GOJOINDUSTRIESINC-CASE5991320WARNINGLETTER","AcknowledgementLetter""2020-2224","03/11/2020","Harrison,Ronall","AMBIEN-AER","Closed""2020-2225","03/11/2020","DhanvantariAIIndiaPvtLtd","2019-119952019-115242019-114382019-110162019-5863","Closed""2020-2226","03/12/2020","BrennanCollins","1)ListingofallINSPECTIONSwithenddatessinceJuly23,2019(inCSVformat)withthefollowingfields:FACTSInspID,FEINumber,LegalName,Address,City,State,Zip,Country,District,FiscalYear,FDA483,InspectionStartDate,InspectionEndDate,PostedCitations,Classification,ProjectArea,Center,ProductType,FullName,InspectionReason2)ListingofreleasableinspectionCITATIONS(fromFDA'sFACTSdatabase)foreachinspectionsinceJuly23,2019(inCSVformat)withthefollowingcolumns:FACTSInspID,FiscalYear,FEINumber,LegalName,InspectionStartDate,InspectionEndDate,ProductType,ReferenceNumber,ShortDescription,LongDescription,Classification,ProjectArea","AcknowledgementLetter""2020-2227","03/12/2020","CosettePharmaceuticals,Inc.
","SummaryBasisofApprovalforINDOMETHACINSUSPENSION(N018332)-25MG/5ML.
(EGALETUSINC)KindlyContact:800-922-1038,Ext3454","Closed""2020-2228","03/12/2020","BRIDGERMANAGEMENTLLC","EstablishmentInspectionReports,anyObservations,andallcorrespondencebetweenEndologixIncinIrvine,CAandSantaRosa,CAandtheFood&DrugAdministrationfromtheperiodof3/1/16throughpresent.
","AcknowledgementLetter""2020-2229","03/12/2020","AminTalatiWassermanLLP","AnyandallcorrespondencerelatedtoFDA'sJune20,2019lettertoLucyGoods,Inc.
regardingtheregulatorystatusofitsnicotineproducts.
IncludingtheresponsetotheletterfromLucyGoods,Inc.
AnyandallcorrespondenceFDAhashadwithRogueHoldings,LLCregardingthemarketingoftheirnicotinegumandlozengeproducts.
","AcknowledgementLetter""2020-2230","03/12/2020","Sheehan&Associates,P.
C.
","InternationalIceCreamAssociation(IICA),February23,1990,foodstandardpetitionswhichasksFDAtoamendthestandardofidentityforicemilktochangethenameofthefoodto"reducedfaticecream"andtoestablishstandardsofidentityforproductsdesignatedas"lowfaticecream"and"nonfaticecream.
"etc","AcknowledgementLetter""2020-2231","03/12/2020","JonasLabs","Allclinicaltrialdata(includingbutnotlimitedtoPhaseI,PhaseII,PhaseIII)thatwasincludedintheNewDrugApplicationforAldaratotreatexternalgenitalandperianalwarts.
AldarawasfirstFDAapprovedforthetreatmentofexternalgenitalandperianalwartsin1997.
","Closed""2020-2232","03/12/2020","KennedysCMKLLP","InrelationtotheOpioidCrisisinvestigationsandlitigation,pleaseprovideallnon-privilegeddocumentsrelatedtotheamountandnatureoffinessoughtfromthemanufacturersanddistributorsofopioids,aswellastheexecutivesorofficersthereof,andincludingtheretailchainstoresandpharmaciesthatsoldthemedications.
","Referral(OutsideFDA)""2020-2233","03/12/2020","BARCLAYS","2020-738,2020-1003,2020-1005,2020-1017,2020-1018,2020-1021,2020-1128,2020-1281,2020-1377,2020-1392,2020-1411,2020-1505,2020-1576,2020-1629,2020-1656,2020-1720.
Thanks","Closed""2020-2234","03/12/2020","QBioMedInc;c/o:CertusInternationalInc","ANDA075941","AcknowledgementLetter""2020-2235","03/12/2020","AlnylamPharmaceuticals","CORDENPHARMACAPONAGO(IT)-HumanDrugs(AsepticOperations)PleaseprovideEIRs,483s&WarningLettersforthissiteinItaly.
","Closed""2020-2236","03/12/2020","Xproassociates,LLC","483issuedtoSumitomoDainipponPharmaCo.
,Ltd.
locatedatSuzuka,Japan;OnCDERDrugQualityAssuranceInspection","Closed""2020-2237","03/12/2020","JOHNSHOPKINSUNIVERSITY","Approvalpackagesfor19530Ucephansodiumphenylacetate,sodiumbenzoate20044Exosurfcolfoscerilpalmitate,cetylalcohol,tyloxapol","Closed""2020-2238","03/12/2020","AnthonyLauzon","NiaTherapeuticsorUniversityofPennsylvaniainvestigationaldeviceexemptionsandresearchdevicesthatinvolveimplantablegraphenenanotechnologyandcircuitry.
","AcknowledgementLetter""2020-2239","03/12/2020","BrandonMartin","Iamrequestinganycorrectiveaction,visualresponse,regardingcomplaintorsimilaractionsregardingwhattheFDAdidregardingcomplaint158306.
","NoRecord(s)""2020-2240","03/12/2020","jiechen","medicalmasks","Delogged(notaFOIARequest)""2020-2241","03/12/2020","MichaelMaturlak","-RequestingcopyofFDAofficeofcriminalinvestigationsreportdatedaroundNovember/December2019etc","ClosedDenial""2020-2242","03/12/2020","AmorepacificUS,Inc.
","ArequestoftheFDAsampleanalysisreportandassociatedtestmethodsand/orproceduresonthearticlefromtheEntrynumberAN1-0617977-1(DivisionofWestCoastImports)onLine11/4IF.
JEJUCOLORPICKERPALETTE","AcknowledgementLetter""2020-2243","03/12/2020","KellerandHeckmanLLC","FoodContactNotification(FCN)1716","AcknowledgementLetter""2020-2244","03/12/2020","DhanvantariAIIndiaPvtLtd","2020-11342020-14092020-14672020-14802020-1484","Closed""2020-2245","03/12/2020","Sheehan&Associates,P.
C.
","Requestsforopinionsandcorrespondencerelatedtothelabelingofvanillinmadefromnaturalprocesses","AcknowledgementLetter""2020-2246","03/12/2020","PROPUBLICA","writtencorrespondence,includinglettersandemails,betweenyouragencyandtheofficeofSenatorDavidPerduefromJanuary2015topresent.
","Closed""2020-2247","03/12/2020","FOIServices,Inc.
","AmagPharmaceuticals,Waltham,MA:EIRs,483sforthefollowinginspections:04/05/2019,10/22/2018,05/21/2014,02/07/2013,08/03/2011","AcknowledgementLetter""2020-2248","03/12/2020","TriviumVet","SummaryBasisofApproval(FreedomofInformation)forOmeprazole(refN022032)andRapamune(RefN021110).
","Closed""2020-2249","03/12/2020","CentrumBrokingLtd","DrReddy'sForm483with3observations.
AuditofAPIManufacturingPlant-5atMiryalaguda,NalgondaDistrict,Telangana","Closed""2020-2250","03/12/2020","TrinidadBenhamCorporation","TrinidadBenham-Mineola322FreemanStMineola,TX75773","NotReasonablyDescribed""2020-2251","03/12/2020","CiplaUSA,Inc.
","February-March2020-humandrug483inspectionobservationsandanyavailableresponsesfor:MaccoOrganiquesInc.
,Salaberry-de-ValleyfieldCanadaFEI3002807518","WithdrawnClosedw/oCharges""2020-2252","03/12/2020","Lumosatherapeuticsinc","53305A[N17001]Ancobon(Hoffmann-LaRoche):Approvalletter,Chemistry,Pharmacology,MedicalOfficerReview,Microbiology,Memos","Closed""2020-2253","03/12/2020","BostonBusinessJournal","communication,recordsandinspectionreportsrelatedtoIntarcia'snewdrugapplicationforITCA650,whichthecompanyresubmittedonSept.
9.
ThisincludesanycommunicationbetweenIntarciaandtheFDA,inspectionsofIntarcia'sBostonandHayward,Californiafacilities,Form483sandotherdocumentsrelatedtotheITCA650application.
","PartialResponse""2020-2254","03/12/2020","MyersonLLC","510Ksubmissionfileforpremarketsubmission#K162572","Closed""2020-2255","03/12/2020","CentrumBrokingLtd","DrReddy,Revisedform483with1observation.
FormulationsManufacturingPlant-3atBachupally,Hyderabad.
","Closed""2020-2256","03/12/2020","HORTONOBERRECHTETAL","DARRIGOBROSCO-LETTUCEECOLIRECALL","AcknowledgementLetter""2020-2257","03/12/2020","DCCC","CORRBETWEENREPDONBACON&FDA1/1/17TO3/11/20","Closed""2020-2258","03/12/2020","ICUREPHARMACEUTICALINC","DMF032719","Closed""2020-2259","03/13/2020","HikmaPharmaceuticalsUSAInc.
","MostrecentlyapprovedlabelingforNDA00803thatcontainstheinjectabledosageformandanyinformationthatispubliclyavailableregardingtheformulationcompositionofApresoline20mg/mL.
","Closed""2020-2260","03/13/2020","FordHeilizer","AcopyofallIPaddressesthatvisited:https://esg.
fda.
gov/loginoverthepastweek.
PleaseobfuscatethefourthoctetoftheIPaddressesinordertopreservetheprivacyoftheusers(ex:79.
235.
130.
XX).
","WithdrawnClosedw/oCharges""2020-2261","03/13/2020","ScaleLaw","WepleaseneedthedocumentsandrecordsconcerningthefollowingPeruvianfishprocessingplantlocatedat:AV.
INDUSTRIALZ.
I.
ZONAINDUSTRIALIILOTE.
05MZ.
R/PIURA-PAITA-PAITAPeru,051FDA#17843713768Plant#P293-PAI-DEBUCIQ#60415000086UponinformationandbeliefthePlantusedtoberegisteredtoDeeperBlueSea,andtheregistrationwaschangedtoAltamarFoodsPeru.
Wealsopleaseneedanydocumentsrelatedtothechangeofregistration","Closed(Fee-related)""2020-2262","03/13/2020","FDAZILLA","2019-11506,2019-11501,2019-11544,2019-11472,2019-11495","Closed""2020-2263","03/13/2020","FDAZILLA","2019-9203,2019-10670,2019-10020,2019-10040,2019-11507.
","Closed""2020-2264","03/13/2020","BeasleyAllenLawFirm","recordsregardingtheDriveMedicalAlternatingPressurePumpandPadSystemItemNo.
14001Eincludingapplications,productreviews,certifications,complaints,investigations,recallinformation,communicationwiththemanufacturerordistributor,andthelikeatanytimeinthepast.
","AcknowledgementLetter""2020-2265","03/13/2020","FOIServices,Inc.
","10FileNumbersregardingAbiomedImpella.
","Closed""2020-2266","03/13/2020","DhanvantariAIIndiaPvtLtd","2020-16542020-8632020-9862020-10242020-1095","Closed""2020-2267","03/13/2020","HamparyanInjuryLawyers","Thisrequestseeksanyandallrecordsregarding"IntravenousCurcuminInfusion"andPEG40CastorOil,particularlyinregardstothiseventandImprimisRX:https://www.
fda.
gov/drugs/human-drug-compounding/fda-investigates-two-serious-adverse-events-associated-imprimisrxs-compounded-curcumin-emulsion","AcknowledgementLetter""2020-2268","03/13/2020","FDAZILLA","2019-10439,2019-5989,2020-962,2020-927,2020-929.
","Closed""2020-2269","03/13/2020","RAYTHOMPSON","LISTOFINSPECTIONS","Closed""2020-2270","03/13/2020","FDAZILLA","KimberlyLewandowski-Walker,WilliamAWarnick,DiannaCSonnenburg,CVs","Closed""2020-2271","03/13/2020","FDAZILLA","2019-11423,2019-11416,2019-11399,2019-11384,2019-11337.
","Closed""2020-2272","03/13/2020","FDAZILLA","The483(inelectronicformat)forFoods&CosmeticsinspectionofNana'sKitchen,Inc.
ending04/07/2010atthelocationinJohnsburgILetc","Closed""2020-2273","03/13/2020","FDAZILLA","The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofPrimeDentalManufacturing,Inc.
ending11/21/2019atthelocationinChicagoIL,UnitedStates.
etc","Closed""2020-2274","03/13/2020","CDRResourceCenter","Companyname,physicaladdress,emailaddress&phone#ofallprescriptiondrugmanufactures,repackagers,wholesalers,listedashavingacurrentestablishmentregistrationwiththeFDA.
","Closed""2020-2275","03/13/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofAjinomotoAlthea,Inc.
ending11/22/2019atthelocationinSanDiegoCA","AcknowledgementLetter""2020-2276","03/13/2020","FDAZILLA","TheEIR(inelectronicformat)forAnimalDrugs&FeedsinspectionofCharlesRiverLaboratoriesCleveland,INC.
ending07/08/2019atthelocationinClevelandOH,UnitedStates.
","AcknowledgementLetter""2020-2277","03/13/2020","FDAZILLA","TheEIR(inelectronicformat)forAnimalDrugs&FeedsinspectionofBachemAmericas,Inc.
ending05/18/2018atthelocationinTorranceCA,UnitedStates.
TheEIR(inelectronicformat)forAnimalDrugs&FeedsinspectionofBachemAmericas,Inc.
ending06/12/2019atthelocationinTorranceCA,UnitedStates.
","Closed""2020-2278","03/13/2020","AmericansforPublicTrust","AnyandallcorrespondencebetweenSen.
SheldonWhitehouseandtheFDAregardingGileadSciencesincludingbutnotlimitedtoemailstoand/orfromsheldonwhitehouse@yahoo.
comaswellasemailstoand/orfromthedomainswhitehouseforsenate.
comandwhitehouse.
senate.
govetc","AcknowledgementLetter""2020-2279","03/13/2020","FOIServices,Inc.
","FileNumber2020-1037","Closed""2020-2280","03/13/2020","SaintMary'sUniversityofMinnesota","June2017InspectionReportforMarkRobbinsinNashville,TN;associatedFDA482;andoutcomeletter.
November2013InspectionReportforNealKleimaninHouston,TX;associatedFDA482;andoutcomeletter.
November2013InspectionReportforJ.
KevinHarrisoninDurham,NCandassociatedFDA482;associatedFDA482;andoutcomeletter.
","AcknowledgementLetter""2020-2281","03/13/2020","HelenHarris","IneedtopseriouscomplaintsconsumersreportedforBosentanTablets,death,sideeffectsandadversereactions.
Ineedtoknowifanyoneelsereportedproblemswithlungcollapsing.
Problemitcausedduringclinicaltrials.
","Closed""2020-2282","03/13/2020","JamieDu","INDIVIDUALRECS","Delogged(notaFOIARequest)""2020-2283","03/13/2020","POLITICO","CommunicationbetweenFDAofficialsandCDC,HHSandtheWhiteHouseonCOVID-19diagnostictesting.
","AcknowledgementLetter""2020-2284","03/13/2020","JOHNSONCONTROLSINC","RequestingacopyofthePerformance&PaymentBondprovidedbyLusardiConstructiontotheFDAfortheprojectlocatedat1201HarborBayParkway,Alameda,CA94502.
RequestingcopiesofallpayapplicationsapprovedandpaidbytheFDAtoLusardiConstructionforthissameprojectlocatedat1201HarborBayParkway,Alameda,CA94502.
RequestingcopiesofchecksissuedfromtheFDAtoLusardiConstructionforalloftheapprovedandpaidpayapplicationsforthissameprojectlocatedat1201HarborBayParkway,Alameda,CA94502.
","Referral(OutsideFDA)""2020-2285","03/13/2020","CONSUMERREPORTS","Anyandallrecordsassociatedwiththecitizen'spetitionfiledbyPublicCitizen,whichaskedtheFDAtobandietarysupplementscontainingcesiumsalts,includingbutnotlimitedtocommunications,memos,documents,testsummaries,andmore,fromthedatethepetitionwasfiledinJuly2018untilthisFOIArequestisprocessed.
","PartialResponse""2020-2286","03/13/2020","JosePadial","SaffronAdulteration,CC160577","AcknowledgementLetter""2020-2287","03/13/2020","GEhealthcarelifescience","IamrequestingstatusinformationonthosetwoMasterfiles:a.
BB-MF7856"HycloneSerumFreemediaproducts"b.
MF13656"Sepaxcellseparationsystem"","AcknowledgementLetter""2020-2288","03/13/2020","PARSONSBEHLE&LATIMER","1)MandatoryReportableFoodReport,submitted02/14/19,FDAICSRID2062654,titled:NephiMill-LarryBankstonDairy.
2)EstablishmentInspectionReport,FEI3007513471,conductedatIntermountainFarmersAssociationNephiMill,2979West6300South,Nephi,UT84648,beginningon02/19/2019andendingon02/22/2019.
3)Allrecordsofanyinvestigations,correspondence,violations,and/orfindingsrelatedto(1)theaboveidentifiedMandatoryReportableFoodReport,and(2)theaboveidentifiedEstablishmentInspectionReport.
","AcknowledgementLetter""2020-2289","03/16/2020","NEWYORKTIMES","notesfromFDAvisitsandphonediscussionswithCDCabouttestkitsfordiagnosingthecoronavirus,COVID-19;recordsfromthevisitofFDA'sDr.
StenzeltoCDC,whereheinspectedaCDClabinAtlanta,andhasraisedquestionsaboutpossiblecontaminationinthelab,and/orinthetestingkits.
","AcknowledgementLetter""2020-2290","03/16/2020","NationalCancerInstitute,DivisionofCancerPrevention","DFMOIND33018wassubmittedbywhatwasthentheNationalCancerInstitute(NCI)'sChemopreventionBranch,DivisionofCancerPreventionandControl(DCPC).
DuringtransferofpapersubmissionsbywhatisnowtheNCI,DivisionofCancerPrevention(DCP),someearlysubmissionsandcorrespondenceforthisINDwerelost.
AsINDsponsor,DCPisrequestingcompletecopiesofserialnos.
000(initialIND),001and004,aswellascopiesofcorrespondencefromandtotheAgencyrelatedtotheinitialINDandsubsequentlythrough1996.
","Delogged(notaFOIARequest)""2020-2291","03/16/2020","XelliaPharmaceuticalsLtd.
","FAERSdatabase,withproductactiveingredient-bacitracinandRoutecodedescription,intramuscular,intraperitoneal,Intravenous(nototherwisespecified),OtherandUnknown.
","Closed""2020-2292","03/16/2020","MedTechReview,LLC","Copiesof483,companiesresponse,andEIRfortheFDAinspectionending09/24/2019forIlluminossMedicalinEastProvidence,RI02914.
","Closed""2020-2293","03/16/2020","ARNOLD&PORTER","RequestforcertificateofauthenticityrelatedtoPlavix","AcknowledgementLetter""2020-2294","03/16/2020","ButlerWeihmullerKatzCraig,LLP","CopiesofalldocumentsinyourpossessionrelatingtotheJanuary10,2020ammonialeakat3776TaylorsvilleHighway,Statesville,NC.
","AcknowledgementLetter""2020-2295","03/16/2020","FAVUSINSTITUTIONALRESEARCHLLC","FDAinspectionreports,includingFDAForm483reportsandFDAEIRreports(EstablishmentInspectionReport)forthedrugmanufacturingsiteatBSPPharmaceuticalsS.
p.
A.
,LatinaScalo,Italy.
","Closed""2020-2296","03/16/2020","KatalystSurgical,LLC","EstablishmentInspectionReportsKatalystSurgical,LLC,754GoddardAvenueofChesterfield,Missouri","Closed""2020-2297","03/16/2020","QuadraTherapeutics","Melphalan(Evomela)OrphanDrugDesignationfor"Highdoseconditioningtreatmentpriortohematopoieticprogenitor(stem)celltransplantation"toAcrotechBiopharmaLLC.
Designated11/24/2008andApprovedforMarketing03/10/2016.
TheOrphanDrugReviewdocumentbyOOPDwilllikelybeNov2008.
","AcknowledgementLetter""2020-2298","03/16/2020","VenaVitals","K020537","AcknowledgementLetter""2020-2299","03/16/2020","TomNamsavanh","FDAApplicationReviewFilesfor:Technelite(NDA017771,LantheusMedical).
","Closed""2020-2300","03/16/2020","LoseyPLLC","AlldocumentsincludingbutnotlimitedtoelectroniccommunicationsconcerninganymeetingsbetweentheU.
S.
FoodandDrugAdministrationandCytocom,ImmuneTherapeutics,oranyofficers,agents,orrepresentativethereof,fromJanuary1,2013throughDecember31,2018includingbutnotlimitedtoanymeetingthatoccurredonMarch23,2018withDr.
ScottGottlieb,RebeccaK.
Wood,andMarshaB.
Henderson.
","AcknowledgementLetter""2020-2301","03/16/2020","RhodesPharmaceuticalsL.
P.
","TheReferenceStandard,AlembicPharmaceuticalsLTDTheophyllineExtended-ReleaseTabletsANDA090430,300and450mgbottlelabelsfor100countand500countpackages.
","Closed""2020-2302","03/16/2020","HikmaPharmaceuticalsUSAInc.
","NDA018654","AcknowledgementLetter""2020-2303","03/16/2020","FAVUSINSTITUTIONALRESEARCHLLC","Wearewritingtorequest,viaFOIA,allFDAinspectionreports,includingFDAForm483reportsandFDAEIRreports(EstablishmentInspectionReport)forthedrugmanufacturingsiteatJohnsonMattheyPharma,Devens,MA,USA.
","Closed""2020-2304","03/16/2020","BZada","2020-16932020-1694","Closed""2020-2305","03/16/2020","EpicPharma,LLC","SuitabilityPetitionNumber85P-0487/CPfromLederleLabs,approvedon01.
28.
1986regardinganapplicationofnewstrength(15mg)ofLeucovorinCalciumTabletsUSP.
etc","Closed""2020-2306","03/16/2020","FAVUSINSTITUTIONALRESEARCHLLC","FDAForm483reportsandFDAEIRreports(EstablishmentInspectionReport)forthedrugmanufacturingsiteatImmunomedics,Inc.
,MorrisPlains,NJ,USA.
","AcknowledgementLetter""2020-2307","03/16/2020","PlasmineTechnology","MemorandaforFCN1174andPNC's1797and1854","Closed""2020-2308","03/16/2020","OFWLAW","SUMMARYOFANIMALFOODFACILITYINSPECTIONS","Closed""2020-2309","03/16/2020","SiemensHealthineers","COR17000611","AcknowledgementLetter""2020-2310","03/16/2020","KleinfeldKaplan&BeckerLLP","Allpetitionsforapprovalofalternativetestingproceduresunder21C.
F.
R.
§355.
70(c)(Testingproceduresforfluoridedentifricedrugproducts)asasubstitutefortheanimalcariesreductiontestingrequiredpursuantto21C.
F.
R.
§355.
70(a),aswellasallFDAresponses.
","Closed""2020-2311","03/16/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-5914,2018-6939,2018-7466,2019-1413,2018-2722.
","Closed""2020-2312","03/16/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-2922,2018-4394,2018-885,2019-731,2018-8152.
","Closed""2020-2313","03/16/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-1787,2018-9127,2018-9130,2018-4234,2019-747.
","Closed""2020-2314","03/16/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-4318,2018-7527,2018-6274,2018-2341,2019-1819.
","Closed""2020-2315","03/16/2020","TheWeinbergGroup","SummarybasisofapprovalforFORANE.
Specifically,thePharmacology/Toxicologyapprovalsummary.
","Closed""2020-2316","03/16/2020","THERESEARCHINVESTMENT,INC.
","PRO3100NC3926-Weekoral(intragastricintubation)toxicitystudyofMDV3100inratsincludingan8-weekrecovery-period.
studyreporteCTDlocation:4.
2.
3.
2.
","WithdrawnClosedw/oCharges""2020-2317","03/16/2020","SiemensHealthineers","TheReferenceforthecomplaintisCOR18000664.
","AcknowledgementLetter""2020-2318","03/16/2020","UChicagoMedicine","imatinib(Gleevec)causingcolonpolyps","Closed""2020-2319","03/16/2020","ChemserviceAmericasLLC","C.
I.
PigmentBrown24CASRN68186-90-3foruseascolorantsetc","AcknowledgementLetter""2020-2320","03/16/2020","FDAZILLA","Pleaseprovidethefollowing3inspection-relateddocumentsinelectronicPDFformat:The483(inelectronicformat)forBiologicsinspectionofBaxaltaUSInc.
ending01/17/2020atthelocationinThousandOaksCA,UnitedStates.
TheEIR(inelectronicformat)forBiologicsinspectionofBaxaltaUSInc.
ending01/17/2020atthelocationinThousandOaksCA,UnitedStates.
TheResponse(inelectronicformat)forBiologicsinspectionofBaxaltaUSInc.
ending01/17/2020atthelocationinThousandOaksCA,UnitedStates.
","AcknowledgementLetter""2020-2321","03/16/2020","FDAZILLA","The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofAlconResearch,LLCending12/05/2019atthelocationinIrvineCA,UnitedStates.
TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofAmcorFlexibles,Commerceending09/14/2017atthelocationinCommerceCA,UnitedStates.
","AcknowledgementLetter""2020-2322","03/16/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofHovioneLLCending01/22/2020atthelocationinEastWindsorNJ,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofAPCERLifeSciences,Inc.
ending06/21/2016atthelocationinPrincetonNJ,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofNovartisPharmaceuticalsCorp.
ending04/22/2015atthelocationinEastHanoverNJ,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofHikmaPharmaceuticalsUSAInc.
ending09/10/2019atthelocationinCherryHillNJ,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofC.
O.
TruxtonInc.
ending06/01/2017atthelocationinBellmawrNJ,UnitedStates.
","AcknowledgementLetter""2020-2323","03/16/2020","UPMPHARMACEUTICALS","MylanPharmaceuticalsInc.
,ChesnutRidgeRdMorgantownWVFacility,483givenon11/18/16","Closed""2020-2324","03/16/2020","CONSUMERREPORTS","CAERSreports:6886168861688616913572442725867296273291732937361974381743997481574817762267706977583780797817878707787877878478987823351360291360291360291393521393521445981471741518811518811518811584611840851840851929461996742066272017-CFS-0026482018-CFS-0012862018-CFS-0030512018-CFS-0030482018-CFS-0045792018-CFS-0080072018-CFS-0082012018-CFS-0119682018-CFS-0119682018-CFS-0150552018-CFS-0151152019-CFS-0001082019-CFS-0001072019-CFS-000315","AcknowledgementLetter""2020-2325","03/16/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofMetroDrugs3rdAvenueCorpending04/05/2019atthelocationinNewYorkNY,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofMetroDrugs3rdAvenueCorpending04/05/2019atthelocationinNewYorkNY,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofMaimonidesMedicalCenter-Pharmacyending07/29/2019atthelocationinBrooklynNY,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofMaimonidesMedicalCenter-Pharmacyending07/29/2019atthelocationinBrooklynNY,UnitedStates.
","AcknowledgementLetter""2020-2326","03/16/2020","CONSUMERREPORTS","483sandEIRsfor:-Aninspectioncompleted11/15/2019ofSoliPharmaB.
V.
,locatedinOudenbosch,Netherlands.
Producttypeis:Food/Cosmeticsetc","AcknowledgementLetter""2020-2327","03/16/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofSMITHSMEDICALASD,INC.
ending04/11/2018atthelocationinOakdaleMN,UnitedStates.
The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofNAMSAending09/03/2010atthelocationinMinneapolisMN,UnitedStates.
The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofNAMSAending02/04/2013atthelocationinMinneapolisMN,UnitedStates.
TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofPlas-TechEngineeringInc.
ending01/24/2011atthelocationinLakeGenevaWI,UnitedStates.
","AcknowledgementLetter""2020-2328","03/16/2020","TheRecord,Inc.
","allemailsregardingasbestosintalcusedincosmeticsbetweenstaffattheCenterforFoodSafetyandAppliedNutritionandemailaddressesfromthefollowingdomainsfromJan.
1,2015tothepresent:-beasleyallen.
com-sgptrial.
com-LanierLawFirm.
com-weitzlux.
com-nsprlaw.
com-napolilaw.
com-simmonsfirm.
com-lawpga.
com-angeloslaw.
com-motleyrice.
com","WithdrawnClosedw/oCharges""2020-2329","03/16/2020","FOIServices,Inc.
","MostRecentListingofallFDA-conductedMRAinspections,includingalldisclosableinformationincludingFEI,companyname,address,country,inspectionstartandenddates,typeoffirm,classificationofoutcomeofinspection,andwhetherornota483wasissued.
","AcknowledgementLetter""2020-2330","03/16/2020","NEOGENCORP","FreedomofInformationDrugSummaryforNADA011-154(NFZPuffer)(e.
g.
https://animaldrugsatfda.
fda.
gov/adafda/app/search/public/document/downloadFoi/1365)HistoricalFOIsummariesnotrequested,onlythesummarythatwouldhavebeenmostrecentlyavailableontheFOIAelectronicreadingroom.
","Closed(Fee-related)""2020-2331","03/16/2020","FinneganLLP","DrugMasterFile(DMF)No.
030222","WithdrawnClosedw/oCharges""2020-2332","03/17/2020","MomsAcrossAmericaandInformedConsentActionNetwork","Documentsreflectingthetestingofvaccinesforthepresenceofglyphosateandtheresultsofanysuchtesting.
","AcknowledgementLetter""2020-2333","03/17/2020","GardinerHarris","PleaseprovidethetranscriptoftheMarch2001PsychopharmacologicAdvisoryCommitteemeetinginwhichRisperdal(risperidone)wasdiscussed.
","Closed""2020-2334","03/17/2020","InformedConsentActionNetwork","Copiesofthelotreleasespot-testingperformedbytheFDAfortheRecombivaxHBvaccinebetweenJanuary1,2017andDecember31,2018.
","AcknowledgementLetter""2020-2335","03/17/2020","InformedConsentActionNetwork","1.
AcopyofanyletterfromtheFDAtoMerckregardinganyinspectionatanytimebetweenJanuary1,2017andMarch2020bytheFDAofMerck'sfacilityorfacilitiesthatmanufactureRecombivaxHB;2.
Anyresponse(s)issuedbyMerckwithregardtoanyletterdisclosedpursuanttothefirstnumberedrequestabove;and3.
AcopyofanylettersentfromtheFDAtoMerckcitinganydeviationbyMerckfrommanufacturingguidelinesforRecombivaxHB.
","AcknowledgementLetter""2020-2336","03/17/2020","UnitedPharma","482483","NotReasonablyDescribed""2020-2337","03/17/2020","BaxterHealthcareCorporation","SummaryBasisofApprovaldocumentsforPotassiumPhosphatesInjection,USP(NDA212121)","WithdrawnClosedw/oCharges""2020-2338","03/17/2020","CONSUMERREPORTS","Anyandallrecords,suchasaninternaloremployeeguide,pertainingtohowCFSANemployeesaresupposedtohandleandprocessanadverseeventreportintotheCAERSdatabase.
","DuplicateRequest""2020-2339","03/17/2020","BaxterHealthcareCorporation","SummaryBasisofApprovaldocumentsforPotassiumPhosphatesInjection,USP(NDA212832)","WithdrawnClosedw/oCharges""2020-2340","03/17/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofXelliaPharmaceuticalsUSALLCending01/31/2020atthelocationinBedfordOH,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofPatheonPharmaceuticalsIncending12/13/2019atthelocationinCincinnatiOH,UnitedStates.
","AcknowledgementLetter""2020-2341","03/17/2020","EugeneSumin","ProtegeEverflexSelf-ExpandingBiliaryStentSystem(K060057).
","AcknowledgementLetter""2020-2342","03/17/2020","FinneganLLP","DrugMasterFile(DMF)No.
031791","WithdrawnClosedw/oCharges""2020-2343","03/17/2020","AltriaClientServicesLLC","AltriaClientServicesLLC("ALCS"),onbehalfofPhilipMorrisUSAInc.
(PMUSA)1,requestscompleteunredactedreviewer'ssummariesandanyassociatedsupportingmemorandaforSE0015281forwhichthedeterminationwasreceivedonMarch13,2020.
","Closed""2020-2344","03/17/2020","FDAZILLA","The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofUniversityofKentuckyending11/21/2019atthelocationinLexingtonKY,UnitedStates.
TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofUniversityofKentuckyending11/21/2019atthelocationinLexingtonKY,UnitedStates.
","PartialDenial""2020-2345","03/17/2020","EugeneSumin","EluNIRRidaforolimusElutingCoronaryStentSystem(P170008).
","AcknowledgementLetter""2020-2346","03/17/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofL.
PerrigoCompanyending10/22/2019atthelocationinHollandMI,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofAITBiosciencesending06/28/2019atthelocationinIndianapolisIN,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofPaulA.
Benson,D.
O.
ending02/12/2015atthelocationinBerkleyMI,UnitedStates.
etc","Closed""2020-2347","03/17/2020","Xproassociates,LLC","483issuedtoTerumoYamaguchiD&DCorporation;LocatedatYamaguchi,Japan;onFDACDERinspection;","Closed""2020-2348","03/17/2020","FDAZILLA","TheEIR(inelectronicformat)forFoods&CosmeticsinspectionofLannettCompanyInc.
ending07/23/2018atthelocationinSeymourIN,UnitedStates.
","AcknowledgementLetter""2020-2349","03/17/2020","EugeneSumin","SuperaPeripheralStentSystem(P120020).
","AcknowledgementLetter""2020-2350","03/17/2020","Verathon,Inc.
","EIRVerathon,Inc.
20001NorthCreekParkwayBothell,WA98011ProductType:MedicalDevices","Closed""2020-2351","03/17/2020","VirbacCorporation","483ssinceJanuary2018fromFareva'sZoneindustrielledePocé-sur-Cisse,29Ruedel'industrie,Francesite.
","Closed""2020-2352","03/17/2020","CiplaLimited","SupplementandamendmentsofVoltarenArthritisPain(diclofenacsodium)topicalgel,1%,NDA22122.
","Closed""2020-2353","03/17/2020","TestTest","TEST","Delogged(notaFOIARequest)""2020-2354","03/17/2020","TexasPublicHealthSolutionsLLC","Pleasesendmethelast3FDAhealthinspectionreportsforthefollowingAmazonFreshWarehousefacility:PrimeNowLLC,6627MapleAvenue,Dallas,TX75235","Closed(Fee-related)""2020-2355","03/17/2020","AccordHealthcareInc.
","ANDA#209713","WithdrawnClosedw/oCharges""2020-2356","03/17/2020","WheatonPharmaceuticals,LLC","ForNDA020657-1.
Theanimalpharmacology/toxicityreview;2.
Summaryrevieworoverallreviewconclusions.
","Closed""2020-2357","03/17/2020","NeogenCorporation","FreedomofInformationDrugSummaryforNADA011-154(NFZPuffer)(e.
g.
https://animaldrugsatfda.
fda.
gov/adafda/app/search/public/document/downloadFoi/1365)HistoricalFOIsummariesnotrequested,onlythesummarythatwouldhavebeenmostrecentlyavailableontheFOIAelectronicreadingroom.
","AcknowledgementLetter""2020-2358","03/17/2020","ACell,Inc.
","K051647","AcknowledgementLetter""2020-2359","03/17/2020","WebMD","UndertheU.
S.
FreedomofInformationAct,I'mrequestingcopiesofallemailstoandfromDr.
TimothyStenzelthatcontainanyofthefollowingterms:"test""RT-PCR""PCR""CDC"Alongwithanyoftheseterms:"COVID""COVID-19""Coronavirus"Thankyou.
","AcknowledgementLetter""2020-2360","03/17/2020","HuffPost","FDAcommunicationsregardingalternativeorplant-basedmeatanddairyproducts","NotReasonablyDescribed""2020-2361","03/17/2020","Medopad","K190792K173028","AcknowledgementLetter""2020-2362","03/17/2020","KurarayNoritakeDentalInc.
","K103556","AcknowledgementLetter""2020-2363","03/17/2020","BrennanCollins","LISTINGOFINSPECTIONS","AcknowledgementLetter""2020-2364","03/17/2020","KevinPerry","PleasesendmeallthesafetyandeffectivenessdataforNaprosyn325mgBID.
","Closed""2020-2365","03/17/2020","NomuraFinancialAdvisory&Securities(India)PrivateLimited","Needform483withfourobservationsissuedtoAlmebicPharmaforOralSolidFormulationFacilitylocatedatPanelavforUSFDAinspectionheldduringMarch2020.
","NoRecord(s)""2020-2366","03/17/2020","HaroldHoffman","ALLrecordsanddocumentsconcerningtheFDAinspectionofthedrugmanufacturingfacilityofKingBio,Inc.
,FEI1053442,at3WestsideDrive,Asheville,NCwhichtookplaceJuly9-20,2018","AcknowledgementLetter""2020-2367","03/17/2020","AlexionPharmaceuticals,Inc.
","FAERSQueryfor:Repatha,PushtronexOn-BodyInfusorDeviceAnyreportsrelatedtodeviceissues,use,malfunctions,etc.
","Closed""2020-2368","03/17/2020","ChristopherFallon","writtencorrespondence(includingemailsandletters)betweenAdamas,Inc.
andtheFDAwithrespecttosafetyandefficacyofGOCOVRI(previouslyADS5102)fortreatmentofdyskinesiainpatientswithParkinson'sdiseasereceivinglevodopa-basedtherapy,aswellas,forthetreatmentofmultiplesclerosiswithwalkingimpairment("MSWI").
","AcknowledgementLetter""2020-2369","03/17/2020","DhanvantariAIIndiaPvtLtd","2020-9782020-9792020-9802020-9822020-994","Closed""2020-2370","03/17/2020","DhanvantariAIIndiaPvtLtd","2020-9952020-6642020-14052020-13282020-322","Closed""2020-2371","03/17/2020","DhanvantariAIIndiaPvtLtd","2020-6862020-5672020-5362020-5072020-462","Closed""2020-2372","03/17/2020","WatersKrausLLP",""PackagingFoodforYou".
","AcknowledgementLetter""2020-2373","03/17/2020","InformedConsentActionNetwork","Copiesofalldocumentsandrawdatareliedupontoreportthe1469childdeathslistedinTable1oftheaforementionedstudy.
","Referral(OutsideFDA)""2020-2374","03/17/2020","DrAjayPhadke","Form483forAlembic'sPanelavUnit","NoRecord(s)""2020-2375","03/17/2020","FDAZILLA","2017-2983,2017-6396,2019-7549,2019-9959,2019-11184.
","Closed""2020-2376","03/17/2020","FDAZILLA","2019-10427,2019-11159,2020-925,2020-918,2020-936.
","Closed""2020-2377","03/17/2020","ExponentInc.
","AnyandallmaterialsrelatedtoGRNNo.
893,includingbutnotlimitedtotheGRNitself,correspondenceontheGRN,andanyFDAinternalmemos.
","Closed""2020-2378","03/17/2020","GoldenGateSoyProductsInc","AllForm483forGoldenGateSoyProducts,Inclocatedat1265GriffithStreetSanFranciscoCA94124","AcknowledgementLetter""2020-2379","03/17/2020","MotilaloSwalSecuritiesLimited","Requestforform483withrespecttorecentUSFDAinspectionatformulationfacilityofAlembicPharmaceuticalslocatedatPanelav.
","NoRecord(s)""2020-2380","03/17/2020","FDAZILLA","2020-924,2020-785,2020-777,2020-536,2020-322.
","AcknowledgementLetter""2020-2381","03/17/2020","FDAZILLA","2019-1004,2019-1981,2017-1946,2019-3061,2018-3366.
","Closed""2020-2382","03/17/2020","510KFDACONSULTING","K083811","AcknowledgementLetter""2020-2383","03/17/2020","BRYANT,KATHY","test","Delogged(notaFOIARequest)""2020-2384","03/17/2020","TestTest","testtest","Delogged(notaFOIARequest)""2020-2385","03/18/2020","TheSeattleTimes","AnyandallapplicationssubmittedtotheFDAundertheEmergencyUseAuthorizationfornovelcoronavirusrelatedtodiagnostictestsforSARS-CoV2and/orCOVID-19,includinganyandallapplicants'submissionsofpopulatedEUAreviewtemplatesrelevanttodiagnostictestsandanyandallsubsequentcommunicationsbetweentheFDAandapplicantaboutthepre-EUAappllication.
","AcknowledgementLetter""2020-2386","03/18/2020","KaiserHealthNews","Pleaseprovideallemailstodrugshortages@fda.
hhs.
govandallresponsesfromFDAofficialsorcontractorsfrom2-3-20topresent.
","AcknowledgementLetter""2020-2387","03/18/2020","FDAZILLA","CVRaquelGonzalezRivera,JohnALiu,R.
TerryBolen,JamieSMathews,ETC","Closed""2020-2388","03/18/2020","SouthernInstituteforMedicalandLegalAffairs,LLC","AnyandalldocumentsprovidedtotheFood&DrugAdministrationunderSection904(b)asrequestinginExhibitAattachedhereto,LetterfromMatthewR.
Holman,P.
h.
D.
,DirectoroftheOfficeofScience,CenterforTobaccoProductsoftheU.
S.
Food&DrugAdministrationtoMr.
ZiadRouagofJuulLabs,Inc.
datedApril24,2018.
","AcknowledgementLetter""2020-2389","03/18/2020","GUIDELINEMEDICAL","K123795K032833","Closed(Fee-related)""2020-2390","03/18/2020","BenjaminL.
England&Associates,LLC","TraceabilitydataregardingFDA'scyclosporaoutbreakinvestigationofimportedfreshbasil","AcknowledgementLetter""2020-2391","03/18/2020","KIRKLAND&ELLISLLP","AnyandalldocumentsandcommunicationsconcerningtheperformanceoftheINRatioorINRatio2PT/INRtestingdevicesandtestingstrips,includingbutnotlimitedtothedevices'performanceintheRocketAFtrial.
","AcknowledgementLetter""2020-2392","03/18/2020","AltriaClientServicesLLC","AltriaClientServicesLLC("ALCS"),onbehalfofPhilipMorrisUSAInc.
(PMUSA),requestscompleteunredactedreviewer'ssummariesandanyassociatedsupportingmemorandaforSE0015608andSE0015609forwhichthedeterminationwasreceivedonMarch12,2020.
","Closed""2020-2393","03/18/2020","DEERFIELDINSTITUTE","Agendaandmeetingminutesofthe2/26/20meetingwithJeffreyShurenandothers,subject:"DiabeticDevices,CybersecurityandRenalDenervationUpdates"-https://www.
fda.
gov/news-events/public-calendar-meetings-fda-officials/public-calendar-february-23-29-2020","AcknowledgementLetter""2020-2394","03/18/2020","FDAZILLA","1)ListingofallINSPECTIONSsinceMonday,March18,2019(inCSVformat)withthefollowingfields:FEINumber,InspectionStartDate,InspectionEndDate,LegalName,Address,CityName,StateCode,ZipCode,CountryName,FDA483,FullName,District,Center,INSPECTIONREASON2)ListingofreleasableinspectionCITATIONS(fromFDA'sFACTSdatabase)foreachcompanysinceMonday,March18,2019inCSVformatwiththefollowingcolumns:INSPECTION_ID,YEAR,INSPECTION_START_DATE,INSPECTION_END_DATE,FEI_NUMBER,FIRM_Name,REF_NO,SHORT_DESC,InspectionClassification,InspectionProjectArea.
","AcknowledgementLetter""2020-2395","03/18/2020","DCCC","alllogsofcongressionalcorrespondencetoorfromanyofficialsatFoodandDrugAdministrationandRep.
BrianFitzpatrickbetweenJanuary1,2017,andMarch16,2020.
","Closed""2020-2396","03/18/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofBectonDickinson&Co.
ending08/04/2017atthelocationinSparksMD,UnitedStates.
TheResponse(inelectronicformat)forMedicalDevices&RadHealthinspectionofBectonDickinson&Co.
ending08/04/2017atthelocationinSparksMD,UnitedStates.
","AcknowledgementLetter""2020-2397","03/18/2020","UnitedStatesPharmacopeialConvention(USP)","AdverseEventReports(AERs)relatingtoGARCINIAINDICAfromtheCAERSdatabase.
","WithdrawnClosedw/oCharges""2020-2398","03/18/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofPfizerPharmaceuticalsLLCending12/20/2019atthelocationinBarcelonetaPR,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofAbbvieLTDending12/21/2018atthelocationinBarcelonetaPR,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofAmgenManufacturingLtdending04/29/2011atthelocationinJuncosPR,UnitedStates.
","Closed""2020-2399","03/18/2020","UnitedStatesPharmacopeialConvention(USP)","AnydocumentsdevelopedbytheFDArelatedtoGRASnoticeGRNNo.
595forGAMMA-AMINOBUTYRICACIDacidbeforeitwaswithdrawnfromFDAevaluation.
","AcknowledgementLetter""2020-2400","03/18/2020","UnitedStatesPharmacopeialConvention(USP)","AdverseEventReports(AERs)relatingtoGARCINIACAMBOGIAorGARCINIAGUMMI-GUTTAfromtheCAERSdatabase.
Note:Garciniacambogiamaybefrommulti-ingredientdietarysupplementproducts.
","AcknowledgementLetter""2020-2401","03/18/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofEonLabsIncending08/13/2015atthelocationinWilsonNC,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofSyneosHealthending08/05/2019atthelocationinMorrisvilleNCETC","AcknowledgementLetter""2020-2402","03/18/2020","510KFDACONSULTING","Fulltextof510(k)petitionK030883OmniluxBlue_x000D__x000D_Fulltextof510(k)petitionK043329OmniluxReviveadBlueCombination_x000D_","AcknowledgementLetter""2020-2403","03/18/2020","HuffPost","RECSWITHMANUFACTURERSRESCHOOLLUNCHETC","AcknowledgementLetter""2020-2404","03/19/2020","REACH24HCONSULTINGGROUP","FCN83and725","Hold""2020-2405","03/19/2020","RichardMarlonStein","Employeecountforinspectorsbyproducttype","AcknowledgementLetter""2020-2406","03/19/2020","ASSOCIATEDPRESS","copiesofemailsregardingtheemergencyuseauthorizationforCOVID-19testkitsdevelopedbytheU.
S.
CentersforDiseaseControlandPreventionintheemailaccountsofthefollowingindividuals:StephenHahnAmyAbernethyJeffreyShurenTocollecttherecords,pleasesearchtheemailaccountsspecifiedaboveforthefollowingterms:"coronavirus","covid","nCov","emergencyuseauthorization".
ThedaterangefortherequestisJan.
302020toFeb.
6,2020ANDFeb.
20,2020toFeb.
29,2020.
Iwouldliketherecordscollectedthroughsearchesoftheagency'sstoredemailsystem.
","AcknowledgementLetter""2020-2407","03/19/2020","VENABLELLP","Iamrequestingcopiesofanyandalldocuments,information,inspectionreports,andcommunicationsrelatedtoEcocoInc.
andTalyoniLLC.
","NotReasonablyDescribed""2020-2408","03/19/2020","AlexAggen","1.
Anyandalldocumentsinconnectionwithanyreview,examinationand/ormeetingsregardingBagelWorksBreadCompany/BagelWorksCafé,Inc.
/PizziniandHansen,Inc.
(the"Entities"),andtheEntities'operationsat1523S.
45thStreet,KansasCity,Kansas66106,FEI3002673045(the"Facility")fromJanuary1,2016tothedateofyourresponsetothisrequest.
etc","Hold""2020-2409","03/19/2020","VaziriLawGroup","AllrecordspertainingtotheE.
ColiO157:H7outbreaklinkedtoamultistateoutbreakfrominfectedromainelettucefromtheYumagrowingregionwhichcausedillnessesinpeoplebetweenthedatesofMarch13,2018toJune6,2018,includingbutnotlimitedtotheunredactedMasterTracebackDiagramatendoftheFDA'SMemorandumonthesubjectoutbreak.
"","Closed""2020-2410","03/19/2020","AnthonyLauzon","anyandalldocumentsrelatingtoNiaTherapeutics,CorteraNeurotechnologiesorUniversityofPennsylvaniainvestigationaldeviceexemptionsandresearchdevicesthatinvolveimplantablenanotechnologyandcircuitry.
","DuplicateRequest""2020-2411","03/19/2020","GUIDELINEMEDICAL","K12379506/03/2014Axon-BusProstheticSystemOttoBockHealthCareProductsGmbHK03283309/23/2003MyoSystemOTTOBOCKHEALTHCARE,LP","AcknowledgementLetter""2020-2412","03/19/2020","PCCA","PCCA,HOUSTON,TXEIR02/25/2019","AcknowledgementLetter""2020-2413","03/19/2020","COGENCYGLOBALINC.
","2019-10519","Closed""2020-2414","03/19/2020","COGENCYGLOBALINC.
","2020-247","Closed""2020-2415","03/19/2020","COGENCYGLOBALINC.
","2019-9527","Closed""2020-2416","03/19/2020","LIFEEXTENSION","UnitedPharma2317MooreAvenueFullerton,CA92833482,483","AcknowledgementLetter""2020-2417","03/19/2020","COGENCYGLOBALINC.
","2019-10290","Closed""2020-2418","03/19/2020","COGENCYGLOBALINC.
","2019-10363","Closed""2020-2419","03/19/2020","COGENCYGLOBALINC.
","2019-10368","Closed""2020-2420","03/19/2020","FOIServices,Inc.
","2018-2234,2018-783,2018-9128,2019-3322,2019-1708","Closed""2020-2421","03/19/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-8305,2018-69,2018-4456,2018-443,2018-5485.
","Closed""2020-2422","03/19/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-8407,2018-5394,2018-6371,2019-5451,2018-7006.
","Closed""2020-2423","03/19/2020","FOIServices,Inc.
","CopyoftheFDAresponsetothefollowingfilenumbers:2018-1135,2018-4444,2018-1964,2018-9454,2018-629.
","Closed""2020-2424","03/19/2020","TakedaVaccines,Inc","SanofiDengvaxiaBLASTN125682.
0:Module2.
5(ClinicalOverview)","Hold""2020-2425","03/19/2020","COGENCYGLOBALINC.
","2019-10728","Closed""2020-2426","03/19/2020","EnvironmentalDefenseFundandEnvironmentalWorkingGroup","documentsreferencedintwopeer-reviewedjournalarticlesauthoredbyFDA'sfoodadditivescientiststhattheagencyusedtowritethearticlebutarenotpubliclyavailable.
","AcknowledgementLetter""2020-2427","03/19/2020","NutrasourceDiagnosticsInc.
","originalsubmissionandcorrespondencesofGRN893(psicose).
","Closed""2020-2428","03/19/2020","LaJollaPharmaceuticalCompany","RequestingadverseeventcasesforsuspectproductnameGIAPREZA.
GIAPREZAisLaJollaPharmaceutical'scommercialproduct.
WearespecificallyrequestingthefollowingCaseIDs:16773710,17021213,17075044,17240951.
","Closed""2020-2429","03/19/2020","KleinfeldKaplanandBeckerLLP","Alldocumentsandcorrespondencerelatedtoorinsupportofpremarkettobaccoapplications(PTMAs)filedfortheVuseandLogicENDSproducts","AcknowledgementLetter""2020-2430","03/19/2020","TripleGateCapital,LP","Hello,IwouldliketorequestanyForm483reports(and/ortheEIR)issuedduring2020toImmunomedics,Incasaresultofthere-inspectionoftheirmanufacturingfacilitylocatedinMorrisPlanes,NJat300TheAmericanRoad,MorrisPlanes,NJ07950.
Thankyou.
","Closed""2020-2431","03/19/2020","COGENCYGLOBALINC.
","2020-387","Closed""2020-2432","03/19/2020","CohenMilsteinSellers&TollPLLC","2008-24302015-18942016-63612018-2113","Closed""2020-2433","03/19/2020","COGENCYGLOBALINC.
","2019-10385","Closed""2020-2434","03/19/2020","MedTruth","I'mrequestingacopyof522PostmarketSurveillancereportfiledunderthestudyname"POPAEandEffectivenessrates,registry"thatwassubmittedtotheFDAon5/30/2019.
The522/requirementnumbersare:PS120106/PSS001.
.
","AcknowledgementLetter""2020-2435","03/19/2020","COGENCYGLOBALINC.
","2019-10384","Closed""2020-2436","03/19/2020","COGENCYGLOBALINC.
","2019-10237","Closed""2020-2437","03/19/2020","COGENCYGLOBALINC.
","2019-10291","Closed""2020-2438","03/19/2020","MITTELDEUTSCHERRUNDFUNK","EIR(EstablishmentInspectionReport)ofInspection/FEInumber:3003885745/FirmName:ZhejiangHuahaiPharmaceuticalCo.
,Ltd.
etc","Closed""2020-2439","03/19/2020","PogustMillrood,LLC","Injectafer98804601025191110357257110972301163424211983659128362191392119514362586146613961540135117076012","Closed""2020-2440","03/19/2020","COGENCYGLOBALINC.
","2019-10896","Closed""2020-2441","03/20/2020","MunchGLPConsulting","ThislistofrecordswasgeneratedfromcopiesofrecordsprovidedtoFDAemployeeEricPittmanbyFDAArchivistHistorianJohnSwann.
","Hold""2020-2442","03/20/2020","ManagementConcepts,Inc.
","(1)CopyofcompletedAuthorization,Agreement,andCertificationofTrainingForms(SF-182s)issuedbetweenOctober1,2018–September30,2019.
","WithdrawnClosedw/oCharges""2020-2443","03/20/2020","TheMarkup","RecordsofallFDAcorrespondencewithAmazon.
comforTheMarkup","NotReasonablyDescribed""2020-2444","03/20/2020","PavneetSingh","FDAEMPLOYEEDATA","AcknowledgementLetter""2020-2445","03/20/2020","THERAPIXEL","ScreenPointMedicalBVK193229Trade/DeviceName:TransparaRegulationNumber:21CFR892.
2090RegulationName:RadiologicalComputerAssistedDetectionAndDiagnosisSoftwareRegulatoryClass:ClassIIProductCode:QDQDateReceived:11/22/2019DecisionDate:03/05/2020","AcknowledgementLetter""2020-2446","03/20/2020","ShawnMusgrave","schedulingofLacosamide(soldunderthebrand"Vimpat")asScheduleV","Closed""2020-2447","03/20/2020","RambollEnvironUSCorporation","Requestingcompletefoodcontactnotification(FCN)#2000andFDA'sreviewdocuments.
","AcknowledgementLetter""2020-2448","03/20/2020","SzmandaLawGroup,P.
C.
","AllprocessapprovalsandregistrationssubmittedbyHaliburtonInternationalFoods,locatedat3855EJurupaSt,Ontario,CA91761pursuantto21CFR117.
","Closed(Fee-related)""2020-2449","03/20/2020","HolistickMedical","AmplatzerPFOOccluder(prev.
StJudeMedical,nowAbbott)andCardioformPFOOccluder(Gore)datasubmittedforapproval,post-approvalstudies,marketstudies,adverseevents,etc.
Thankyou!
","AcknowledgementLetter""2020-2450","03/20/2020","BAXTERHEALTHCARECORPORATION","BaxterHealthcareCorporationrespectfullyrequeststhattheunredactedEIRfromtheOctober15–24,2018inspectionofBaxterHealthcareofPuertoRicolocatedatRouteNo.
3Km144.
2,Guayama,PR,00784","AcknowledgementLetter""2020-2451","03/20/2020","FOIServices,Inc.
","30-daynotificationssubmittedtoFDAbySwedishMatch(includingSwedishMatchUSA,Inc.
)between10/22/19–3/15/20foralllabeling,advertising,marketing,and/orpromotionalmaterialsassociatedwithitsmodifiedrisktobaccoproducts(MR0000020-MR0000029)authorizedbyFDAon10/22/19.
","AcknowledgementLetter""2020-2452","03/20/2020","PreferredRegulatoryConsultingInc.
","RequestforOrphanDesignationforPerflubron[Liquivent(Tm)]designated04/26/2001forTreatmentofacuterespiratorydistressdisease(ARDS)inadults;thesponsorofthesubmissionwas:PFCDevelopment/NewAlliancePharmaceutical;15021VentureBlvdShermanOaks,California91403USA","ClosedDenial""2020-2453","03/20/2020","COGENCYGLOBALINC.
","7-29-2013DrugsafetyCommunicationrelatedtomefloquinehydrochloride,etc","AcknowledgementLetter""2020-2454","03/20/2020","AgilentTechnologies,Inc.
","2019EIRforAgilentTechnologies,7051EagleBlvd.
,Frederick,CO80504(FEI#:3014531850;D-U-N-S#:108757257)","AcknowledgementLetter""2020-2455","03/20/2020","FDAZILLA","TheResponse(inelectronicformat)forBiologicsinspectionofNovartisPharmaceuticalsCorpending08/21/2019atthelocationinMorrisPlainsNJ,UnitedStates.
","AcknowledgementLetter""2020-2456","03/20/2020","DhanvantariAIIndiaPvtLtd","2020-3222019-109142019-104872019-87002020-1276","AcknowledgementLetter""2020-2457","03/20/2020","FOIServices,Inc.
","EIRs,483sforNestleEauClaire,locatedinEauClaire,WI.
","AcknowledgementLetter""2020-2458","03/20/2020","FDAZILLA","The483(inelectronicformat)forFoods&CosmeticsinspectionofPalaceFoodsInc.
ending08/27/2019atthelocationinReadingPA,UnitedStates.
.
","AcknowledgementLetter""2020-2459","03/20/2020","FDAZILLA","TheEIR(inelectronicformat)forHumanDrugsinspectionofLannettCompany,Inc.
ending06/22/2017atthelocationinPhiladelphiaPA,UnitedStates.
TheResponse(inelectronicformat)forHumanDrugsinspectionofLannettCompany,Inc.
ending06/22/2017atthelocationinPhiladelphiaPA,UnitedStates.
etc","AcknowledgementLetter""2020-2460","03/20/2020","FDAZILLA","The483(inelectronicformat)forBiologicsinspectionofCatalentPharmaSolutions,LLCending06/25/2019atthelocationinWoodstockIL,UnitedStates.
TheResponse(inelectronicformat)forBiologicsinspectionofCatalentPharmaSolutions,LLCending06/25/2019atthelocationinWoodstockIL,UnitedStates.
","Closed""2020-2461","03/20/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofPaconManufacturingCorporationending06/20/2017atthelocationinSomersetNJ,UnitedStates.
etc","AcknowledgementLetter""2020-2462","03/20/2020","DhanvantariAIIndiaPvtLtd","2020-4552020-3962020-3932020-3942020-380","Closed""2020-2463","03/20/2020","FDAZILLA","TheEIR(inelectronicformat)forFoods&CosmeticsinspectionofSriSaiBiopharmaceuticalSolutionsLLCending06/12/2006atthelocationinFrederickMD,UnitedStates.
etc","AcknowledgementLetter""2020-2464","03/20/2020","FDAZILLA","TheEIR(inelectronicformat)forHumanDrugsinspectionofSriSaiBiopharmaceuticalSolutionsLLCending09/24/2010atthelocationinFrederickMD,UnitedStates.
etc","AcknowledgementLetter""2020-2465","03/20/2020","SurmasisPharmaceutical","EstablishmentInspectionReport(EIR)forSurmasisPharmaceutical.
","AcknowledgementLetter""2020-2466","03/20/2020","InvaTechPharmaSolution","METHYLPREDNISOLONEANDA87341DocumentsSpecificallythedrugsubstance(32s)anddrugproduct(32p)sections","Closed(Fee-related)""2020-2467","03/20/2020","BioTex,Inc.
","K192891","AcknowledgementLetter""2020-2468","03/20/2020","PharmatechUSA,LLC","ForGeminiPharmaceuticals,Inc.
inCommack,NY11725:NYKDistrictIneedthefullEIR'sconductedonthesedates:02/05/200903/23/201006/01/201106/30/2015","PendingAction""2020-2469","03/20/2020","AltriaClientServicesLLC","unredactedreviewer'ssummariesandanyassociatedsupportingmemorandaforthefollowingSTNsforwhichthedeterminationwasreceivedonMarch18,2020.
STNsSE0015622SE0015633SE0015621SE0015634SE0015618SE0015617","Closed""2020-2470","03/20/2020","BioTex,Inc.
","K200228","AcknowledgementLetter""2020-2471","03/20/2020","AltriaClientServicesLLC","unredactedreviewer'ssummariesandanyassociatedsupportingmemorandaforSE0015624forwhichthedeterminationwasreceivedonMarch19,2020.
","Closed""2020-2472","03/23/2020","CONSUMERREPORTS","anyandallrecordsassociatedwiththewarningletterissuedMarch6toTheJimBakkerShow","PartialResponse""2020-2473","03/23/2020","TIME","-AnyemailsbetweenFDAofficialsandhumandrugfirmsthatsourcetheiractivepharmaceuticalingredientsorfinisheddrugproductsfromChina.
-AnyemailsbetweenFDAofficialsandhumandrugfirmsthatsourcetheiractivepharmaceuticalingredientsorfinisheddrugproductsfromItaly.
-AnyresponsestheFDAreceivedfromthe"morethan180manufacturersofhumandrugs"wherethedrugmanufacturersnotifiedtheFDAofsupplychainconcernsduetotheimpactofCOVID-19orcoronavirusetc","AcknowledgementLetter""2020-2474","03/23/2020","TheSeattleTimes","logofrequestsundertheFreedomofInformationActsubmittedtotheFoodandDrugAdministrationbetweenOct.
1,2019,andMarch12,2020.
Responsiverecordsshouldincludebutnotbelimitedtothoserequestssubmittedtosub-agenciesoftheFDAthatspecificallymention"emergencyuseauthorization"and/or"emergencyuseauthority.
"","AcknowledgementLetter""2020-2475","03/23/2020","BuzzfeedNews","AnyandallemailssentandreceivedbyStephenM.
Hahn,AmyAbernathy,KeaganLenihan,StacyKlineAmin,JudyMcKeekin,NinaL.
Hunter,PeterW.
Marks,JanetWoodcock,LauraCaliguiri,JamesM.
Sigg,AnnaAbram,DenisHinton,andWilliamSlikkermentioningorreferringtocoronavirus,covid-19,real-timert-pcr,"validation"and"primers.
"","AcknowledgementLetter""2020-2476","03/23/2020","ARCHIMEDESPHARMA","K191406","AcknowledgementLetter""2020-2477","03/23/2020","NorthwellHealth","K173780","AcknowledgementLetter""2020-2478","03/23/2020","AdvocateLutheranGeneralHospital","casereportsCanakinumab","Closed""2020-2479","03/23/2020","UNIVERSITYOFILLINOIS","DocumentsregardingNDA018276","Closed""2020-2480","03/23/2020","AnnavonWendorff(studentatStanfordUniversity)","510Ksummary:DEVICE:ShenDaSinuscopeSHENYANGSHENDAENDOSCOPECO.
,LTD510(k)NO:K161298(Traditional)","AcknowledgementLetter""2020-2481","03/23/2020","RiotHealthManagement","K090131","AcknowledgementLetter""2020-2482","03/23/2020","WAStateDept.
ofHealth","consumercomplaint#160030andforthelabresultsforsamples1128141and1121828etc","Delogged(notaFOIARequest)""2020-2483","03/23/2020","HayleyRumback","Anyinspections,warningletters,orviolationsissuedto:SeattleFishCompanyofDenver,CO,ORSFCInternational,ofKansasCity,MO.
","Closed""2020-2484","03/23/2020","LUPINPHARMACEUTICALSINC","RequestforNumberofANDAfilersonMarch14,2011(NCE-1)forLapatinibDitosylateTablets,250mg.
","WithdrawnClosedw/oCharges""2020-2485","03/23/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofBendResearch,Inc.
ending01/24/2020atthelocationinBendOR,UnitedStates.
The483(inelectronicformat)forHumanDrugsinspectionofAltasciencesPreclinicalSeattle,LLCending09/13/2019atthelocationinEverettWA,UnitedStates.
","AcknowledgementLetter""2020-2486","03/23/2020","QRA,LLC","K180111","AcknowledgementLetter""2020-2487","03/23/2020","FDAZILLA","TheEIR(inelectronicformat)forMedicalDevices&RadHealthinspectionofMedtronicPuertoRicoOperationsCo.
ending05/15/2018atthelocationinJuncosPR,UnitedStates.
TheResponse(inelectronicformat)forMedicalDevices&RadHealthinspectionofMedtronicPuertoRicoOperationsCo.
ending05/15/2018atthelocationinJuncosPR,UnitedStates.
","AcknowledgementLetter""2020-2488","03/23/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofTolmar,Inc.
ending01/28/2020atthelocationinFortCollinsCO,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofTolmar,Inc.
ending01/28/2020atthelocationinFortCollinsCO,UnitedStates.
TheEIR(inelectronicformat)forHumanDrugsinspectionofTOLMARInc.
ending03/28/2019atthelocationinFortCollinsCO,UnitedStates.
","AcknowledgementLetter""2020-2489","03/23/2020","CenterforPharmaceuticalInformationandEngineeringResearch","PursuanttotheFreedomofInformationAct(FOIA),Iherebyrequestthefollowing483forms.
Theprodcutareaoffollowinginspectionsaredrugs.
Thankyou.
1.
ZHEJIANGDINGTAIPHARMACEUTICALCO.
,LTDTongxiangCN1/25/20192.
QiluAntibiotics(Linyi)PharmaceuticalCo.
Ltd.
DezhouCN2/22/20193.
QiluPharmaceuticalCo.
,Ltd.
JinanCN2/22/2019","Closed""2020-2490","03/23/2020","VicariousSurgical","K200049","AcknowledgementLetter""2020-2491","03/24/2020","PROPUBLICA","RECSREINSPECTIONOFCDCLAB","AcknowledgementLetter""2020-2492","03/24/2020","PROPUBLICA","TIMOTHYSTENZELEMAILSRECOVID-19,ETC;CALENDARS","AcknowledgementLetter""2020-2493","03/24/2020","PROPUBLICA","COMMISSIONERHAHNEMAILSRECOVID-19ETC,CALENDARS","AcknowledgementLetter""2020-2494","03/24/2020","PROPUBLICA","TIMOTHYSTENZEL,COMMISSIONERHAHNRECSREFEB27CONFERENCECALL","AcknowledgementLetter""2020-2495","03/24/2020","StephenBarrett,MD","483reportsforWestDuluthDistributionCompany,d/b/aCHKNutritionofDuluth,Minnesota,plusallcorrespondencesenttothiscompanyortoMartinHinz,M.
D.
(akaMartyHinz).
","PendingAction""2020-2496","03/24/2020","KitasatoUniversitySchoolofPharmacy","MedicalrevieworMulti-disciplinereviewintheDrugApprovalPackagesofoncologydrugslistedbelow.
1.
crizotinibforNSCLC,approvedonMarch11,20162.
pembrolizumabforHNSCC,approvedonAugust5,2016etc","AcknowledgementLetter""2020-2497","03/24/2020","AndrewGiardina","AllinformationusedtodetermineMintvapingproductsshouldbebanned.
","Closed(Fee-related)""2020-2498","03/24/2020","LIPOCINEINC","TheCenterforDrugEvaluationandResearchsExclusivityBoardmemorandumreflectingitsdecisiontograntnewproduct3-yearexclusivityforJatenzo(testosteroneundecanoate)Capsules,NDA206089","Closed""2020-2499","03/24/2020","BioTex,Inc.
","K830199","AcknowledgementLetter""2020-2500","03/24/2020","DANA-FARBERCANCERINSTITUTE","individualadverseeventsofpatientsreceivingIbrutinibwhodevelopadvancedcardiacconductiondisorders,specificallycompleteatrioventricularheartblock","NotReasonablyDescribed""2020-2501","03/24/2020","FOIServices,Inc.
","patientleveldatafromtheElagolixPhase3studiesElarisEMIandElarisEMII.
","ClosedDenial""2020-2502","03/24/2020","FDAZILLA","LoriJJennings,TaraMHumfeld,LeslieACartmill,etcCVs","AcknowledgementLetter""2020-2503","03/24/2020","INTERNATIONALASSOCIATIONOFCOLORMANUFACTURERS","Alldata,includingallavailablestudiesontheabsorption,distribution,metabolismandelimination(ADME),andonthetoxicokineticsofFD&CBlueNo.
1.
","AcknowledgementLetter""2020-2504","03/24/2020","AbelLawOffices,PCo/b/oInvitrxTherapeutics,Inc.
","Alldocuments(includingbutnotlimitedtofiles,records,notes,transcripts,emails,letters,communications,andreports)relatedtocomplaintspertainingtoInvitrxTherapeutics,Inc.
and/oritsproducts.
","AcknowledgementLetter""2020-2505","03/24/2020","NeurauraBiotechInc.
","K082474K183437K192764etc","AcknowledgementLetter""2020-2506","03/24/2020","PavneetSingh","1)theorganizationalstructureofspecificcenterswithintheFDAand2)thecorrecttitlesandreportingrelationshipsineachoftheoffices.
","AcknowledgementLetter""2020-2507","03/24/2020","CONSUMERREPORTS","CAERSreports,includinganycommunicationsfromthemanufactureroftheproducts:190512,198048,206659,2018-CFS-014837","Closed""2020-2508","03/24/2020","FOIServices,Inc.
","1stChemistryReviewrelatedtotheSEOrdersissuedtoR.
J.
ReynoldsTobaccoCompanyinDecember2018(SE0014763&SE0014764)","AcknowledgementLetter""2020-2509","03/24/2020","CAMPAIGNFORACCOUNTABILITY","1.
Allcommunications,informationalmaterials,talkingpoints,andotherdocumentscreated,possessed,sent,orreceivedbyanyFDAemployee(s)orrepresentative(s)concerningtheApril12,2019updatetothe"QuestionandAnsweronMifeprex"pageoftheFDAwebsitestating"reportsof24deathsofwomenassociatedwithMifeprex.
"","AcknowledgementLetter""2020-2510","03/24/2020","ericcooke","Anyrecordsofinspection(s)performedbytheFDAatthecompany.
","NotReasonablyDescribed""2020-2511","03/24/2020","BuzzfeedNews","StephenM.
Hahn,AmyAbernathy,KeaganLenihan,StacyKlineAmin,JudyMcKeekin,NinaL.
Hunter,PeterW.
Marks,JanetWoodcock,LauraCaliguiri,JamesM.
Sigg,AnnaAbram,DenisHinton,andWilliamSlikkermentioningorreferringtocoronavirusorcovid-19andanyofthefollowingterms:"emergencyuseauthorization;""Roche;""ThermoFisher;""diagnostictest.
"","AcknowledgementLetter""2020-2512","03/24/2020","THEASSOCIATEDPRESS","Anyandallcommunications,documents,emails,messagesandotherrecordsrelatedtothedevelopmentofCoronavirustestsbytwoprivatelab-testingcompanies:LaboratoryCorporationofAmericaHoldingsandQuestDiagnostics.
","AcknowledgementLetter""2020-2513","03/24/2020","PROPUBLICA","CopiesofanyandallForm483s(NoticeofInspectionalObservations)fortheCDC'slabinAtlanta,GeorgiathatmanufacturestheCDC'snovelcoronavirustestingkits.
","AcknowledgementLetter""2020-2514","03/24/2020","FOIServices,Inc.
","CopyofthedisclosableportionsofthesupplementalPMAsubmissionsandtheSSED/SS&EsforthefollowingSupplementsforPMAP970051:S137,S180,&S195.
","AcknowledgementLetter""2020-2515","03/24/2020","FOIServices,Inc.
","Copyofthedisclosableportionsoftheapprovallettersandlabeling/packageinsertsforthefollowingSupplementsforPMAP970051:S137,S180,&S195.
","AcknowledgementLetter""2020-2516","03/24/2020","FDAZILLA","TheResponse(inelectronicformat)forHumanDrugsinspectionofFagronCompoundingServicesending06/21/2019atthelocationinWichitaKS,UnitedStates.
etc","Hold""2020-2517","03/24/2020","Kleinfeld,Kaplan&BeckerLLP","K161484(ZIIPDevice)","AcknowledgementLetter""2020-2518","03/24/2020","Johnson&Bell,Ltd.
","-Marketing-Safetycommunication(s)-Recall(s)-LetterstoHealthCareProviders-AdverseEvent(s)-Approval(s)and/orclearance-Medicaldeviceban(s)-Reporting-Classification-Approval(s)-PremarketApproval(s)fortheNuVasiveaffinityplateand/ortheNuVasiveaffixplate","AcknowledgementLetter""2020-2519","03/24/2020","STANFORDUNIVERSITY","CongressmanGreenFDAletterdescribingtheinadequacyofSouthKoreanCOVID-19tests","AcknowledgementLetter""2020-2520","03/24/2020","TheUniversityofAdelaide","NCT00006286SERIOUSADVERSEEVENTS","AcknowledgementLetter""2020-2521","03/25/2020","AmericanOversight","Woodcock,Abernathy,Hahn,Shuren-Allfinaldirectives,orders,decisionmemoranda,orguidanceregardingtestingfor_x000D_severeacuterespiratorysyndromecoronavirus2(SARS-CoV-2),thevirusthat_x000D_causesCOVID-19.
).
","AcknowledgementLetter""2020-2522","03/25/2020","AmericanOversight","AllemailcommunicationssentbyTimothyStenzeltoanyCentersforDiseaseControlandPrevention(CDC)_x000D_officials,includinganyonewithanemailaddressendingincdc.
gov,between_x000D_February14,2020,andFebruary29,2020.
_x000D_AmericanOversighthaslimiteditsrequesttosentmessagesofMr.
Stenzelto_x000D_reducethevolumeofpotentiallyresponsiverecords.
AmericanOversightstill_x000D_requestscompleteemailchains.
So,forexample,ifMr.
Stenzelsentaresponseto_x000D_anincomingmessage,theemailchaincontainingtheinitiallyreceivedmessage_x000D_andtheresponseisresponsivetothisrequest.
)","AcknowledgementLetter""2020-2523","03/25/2020","AmericanOversight","HAHN,SHUREN,ABERNATHY,WOODCOCKCOMMUNICATIONSWITHEXECUTIVEOFFICEOFTHEPRESIDENT","AcknowledgementLetter""2020-2524","03/25/2020","AmericanOversight","Allemailcommunications(includingemailmessages,completeemailchains,_x000D_emailattachments,calendarinvitations)sentbyTimothyStenzel,FoodandDrug_x000D_Administration(FDA)DirectoroftheOfficeofInVitroDiagnosticsand_x000D_RadiologicalHealth,toanyonewithanemailaddressendinginhhs.
gov,fda.
gov,_x000D_nih.
gov,oreop.
gov,betweenFebruary14,2020,andFebruary29,2020.
","AcknowledgementLetter""2020-2525","03/25/2020","AmericanOversight","HAHN,ABERNATHY,SHUREN,WOODCOCKRESCRETESTING","AcknowledgementLetter""2020-2526","03/25/2020","Wondery","1.
Correspondencetoandfromthefollowingpeople:JamesMonsees,AdamBowen,ScottDunlap,ChenyueXing,RichardMumby,StevenBaillie,support@juulvapor.
com2.
Depositionsfromanyoftheabovepeople3.
Documentscontainingthefollowingkeywords:"Vaporized""CultCollective"","AcknowledgementLetter""2020-2527","03/25/2020","EmmaBest","RecordsmentioningordescribinganyimpactontheprocessingofFOIArequestscausedbyCOVID-19AKAtheCoronavirus.
","AcknowledgementLetter""2020-2528","03/25/2020","BLOOMBERGNEWS","allcommunications,emailsanddocumentsregardingFDAsubmissionnumberEUA200001.
","AcknowledgementLetter""2020-2529","03/25/2020","Accountable.
us","StephenHahncorrCOVID-19TaskForce","AcknowledgementLetter""2020-2530","03/25/2020","Accountable.
us","calendarsforDecember2019,andJanuary–March2020forthefollowingindividuals:StephenHahnAmyAbernethyetc","AcknowledgementLetter""2020-2531","03/25/2020","AmericanOversight","STENZEL,HINTON,SCHERF,SHUREN,MAISELEMAILSREEUA,EMERGENCYUSEETC","AcknowledgementLetter""2020-2532","03/25/2020","AmericanOversight","Decisionmemosetcsince1/1/20fromFDACommissionerHahnre:COVID-19_x000D_","AcknowledgementLetter""2020-2533","03/25/2020","TheJamesMadisonProject","copiesofallrecordsinthepossessionorcontroloftheFDA,includingcross-references,memorializingthetotalnumberoftestkitsthathavebeenapprovedbytheU.
S.
GovernmentfordetectingthecoronavirusandthathavebeenshippedoutacrosstheUnitedStates,includingalistingofthelocationstowhichthosetestkitshavebeenshippedandwhentheywereshippedandultimatelyreceived.
","AcknowledgementLetter""2020-2534","03/25/2020","ScottDunn","formsFDA4035submittedtotheFDAbyGileadSciencesforthedrug,remdesivir.
","AcknowledgementLetter""2020-2535","03/25/2020","RockSpringsCapital","DocumentationandresultsfromtheFDAinspectionofImmunomedics'manufacturingfacilitylocatedat300TheAmericanRd,MorrisPlains,NJwhichoccurredin2020.
","AcknowledgementLetter""2020-2536","03/25/2020","KATTENMUCHINROSENMANLLP","excelcopyoftheFDA's"Ever-ApprovedList,"whichIunderstandisalistofdrugproductspurportedtohavebeenapprovedbyFDAsince1938underamarketingapplicationsubmittedpursuanttoFDCAct§505.
","Closed""2020-2537","03/25/2020","SzmandaLawGroup,P.
C.
","AllprocessapprovalsandregistrationssubmittedbyHaliburtonInternationalFoods,locatedat3855EJurupaSt,Ontario,CA91761pursuantto21CFR117.
","AcknowledgementLetter""2020-2538","03/25/2020","FDAZILLA","The483(inelectronicformat)forAnimalDrugs&FeedsinspectionofFougeraPharmaceuticals,Inc.
ending05/29/2018atthelocationinHicksvilleNY,UnitedStates.
The483(inelectronicformat)forAnimalDrugs&FeedsinspectionofFougeraPharmaceuticals,Inc.
ending08/08/2019atthelocationinHicksvilleNY,UnitedStates.
The483(inelectronicformat)forAnimalDrugs&FeedsinspectionofFougeraPharmaceuticalsInc.
ending08/08/2019atthelocationinMelvilleNY,UnitedStates.
","AcknowledgementLetter""2020-2539","03/25/2020","AxcellaHealthInc.
","CYSTAGONNDA020392Originalapplicationapproved15August1994:RequestingFDASummaryReview,CrossDisciplineTeamLeaderReview,Pharmacology/ToxicologyReview,MedicalReviewandClinicalPharmacologyReview.
","Closed""2020-2540","03/25/2020","FDAZILLA","The483(inelectronicformat)forMedicalDevices&RadHealthinspectionofHarmacMedicalProducts,Inc.
ending12/12/2019atthelocationinBuffaloNY,UnitedStates.
etc","AcknowledgementLetter""2020-2541","03/25/2020","FDAZILLA","The483(inelectronicformat)forHumanDrugsinspectionofCharlesRiverLaboratories,Inc.
ending02/11/2020atthelocationinWilmingtonMA,UnitedStates.
etc","AcknowledgementLetter""2020-2542","03/25/2020","Levin,Papantonio,Thomas,Mitchell,Rafferty&Proctor,P.
A.
","1.
AnyandallcorrespondencebetweenFDAandmanufacturersofdevicesclaimingtoclean,disinfectorsanitizeCPAPmachinesusingozonegasorUVlightregardingtheneedforsubmissionofsafetyandeffectivenessdataandtheircurrentviolationoftheFederalFood,DrugandCosmeticAct.
etc","AcknowledgementLetter""2020-2543","03/25/2020","DANA-FARBERCANCERINSTITUTE","individualadverseeventsofpatientsreceivingIbrutinibwhodevelopadvancedcardiacconductiondisorders,specificallycompleteatrioventricularheartblock172073781719345717147199etc","AcknowledgementLetter""2020-2544","03/25/2020","FOIServices,Inc.
","FDAresponsetothe07/27/2018letterfromSenatorElizabethWarrentoFDACommissionerScottGottliebregardingoversightofantibioticsinfoodanimals.
","PartialResponse""2020-2545","03/25/2020","COGENCYGLOBAL,INC","2020-44","Closed""2020-2546","03/25/2020","KellerandHeckmanLLC","WearerequestingFDA'sunredactedNoObjectionLetters(NOLs)9and123,alongwithFDA'sreviewmemorandaandtheoriginalunderlyingsubmissionsrequestingtheNOLs.
","AcknowledgementLetter""2020-2547","03/25/2020","DhanvantariAIIndiaPvtLtd","2019-66152019-47182019-47162019-47152019-4806","AcknowledgementLetter""2020-2548","03/25/2020","MaxSkor","FDA'spre-approvalinspection(PAI)oftheImmunomedics,Inc.
drugsubstanceintermediatemanufacturingfacility.
Thefacilityislocatedat300TheAmericanRoad,MorrisPlains,NewJersey","AcknowledgementLetter""2020-2549","03/25/2020","ASHCRAFT&GEREL","AlldocumentsavailabletothepublicrelatingtoorconcerningtheFDAClassIRecallsofMedtronicMiniMed630Gand670Ginsulinpumps"forincorrectinsulindosing"asdescribedintheFDA'srecallnoticecontainedhere:https://www.
fda.
gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing.