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MakingACEWorkforYou:ImportingFDARegulatedProductsOfficeofEnforcementandImportOperationsandOfficeofInformationSystemsManagementUSFoodandDrugAdministrationOctober20192AgendaOverview:ACEandFDACommoditySpecificInformationInformationandResourcesforAllFDARegulatedProductsWhatisACEHowACEWorksforFDAFDACurrentStatusMostCommonCBPandFDARejectionsCommonDataErrorsFDAFlagsFDAACEFinalRuleChangesKnowtheProductBeingImportedInformationNeededforSubmissionCommonReasonsforCommoditySpecificEntryProcessingDelaysCommoditySpecificResourcesAvoidingDelayswithFDAUsetheSupplementalGuideSummaryFrequentlyAskedQuestionsResourcesFDAPointsofContactforImports3OVERVIEW:ACEANDFDAMakingACEWorkforYou:ImportingFDARegulatedProducts4WhatisACETheAutomatedCommercialEnvironmentisacentralizedsystemforalltransactionsrelatedtoimportsandexports.
Filerselectronicallysubmitallinformationrelatedtoaninboundshipmentandthegovernmentprocessesthetransactionsystematicallyandsendsstatusupdates.
5HowACE&PREDICTWorkforFDAIndustryCBPFDAFileraccessesACEthroughtheAutomatedBrokerInterface,submitsPGAMessageSettoCBPCBPconductsasyntaxvalidationtoensureallmandatorydataispopulated;ifPGAMessageSetiscomplete,CBPwillsendtoFDAforfurtherprocessing.
Entrieswithmissingdatawillpromptanerrormessagebacktothefiler.
DataisstoredinandprocessedbyOASIS,screenedbyPREDICT(PNscreeningifrequired)FDAgeneratesacargodispositionmessageandsendstoCBP*CBPsendsthemessagebacktothefiler*Datathatiselectronicallyvalidatedmaybeautomatically"MayProceeded"123456FDACurrentStatusACEbecamemandatoryinJune2016FinalRuleissuedinNovember2016FDASupplementalGuideversion2.
5.
1releasedApril2018FDAcontinuestoworkcloselywithimporters,brokers,andsoftwaredeveloperstoensureunderstandingandcomplianceoftheACEprocessFDAalsocontinuestocollaboratewithCBPtotroubleshootissuesandmakesystemenhancements7FDACurrentStatusAutomatedMayProceedshaveincreasedinACE,andthepercentageoflinesrequiringmanualreviewhavedecreased.
–In2014,only26%of(ACS)lineswereAutomatedMayProceeds.
–In2018,70%oflineswereAutomatedMayProceeds.
8FDACurrentStatusInACE,FDArequestslessdocuments.
–In2014,approximately3%of(ACS)linesneededadditionalinformationtomakeanadmissibilitydecision(DocumentsRequired).
–In2018,approximately2%of(ACE)linesneededadditionalinformationtomakeanadmissibilitydecision(DocumentsRequired).
9MostCommonCBP&FDARejectsCBPRejectsJan–Sep2019FDARejectsJan–Sep2019MissingorInvalidAffirmationsofComplianceInvalidProductCodeMissingorInvalidEntitiesCancelledFoodFacilityRegistrationMissingorInvalidPG21RecordorIndividualQualifierCodeInvalidState/ZipCombinationMissingorInvalidEntityIDCodeforFEIorDUNSFoodFacilityRegistrationNotonFileMissingorInvalidFEIorDUNSNumberFoodFacilityRegistrationInvalidatedbyPGAOnlyMandatoryEntitiesAllowedMismatchBetweenFoodFacilityRegistrationandManufacturer10CommonDataErrorsAreasforImprovementMustknowtheIntendedUseCodeoftheproductpriortotransmittingentrydata(foodsdonotrequireanIUC)KnowrequiredEntitiesandAffirmationofCompliance(AoC)CodesforcommoditytypeOtherthanthefewrepeatableAoCcodeslistedintheSG,donotsubmitthesameAoCcodemorethanonceperlineSubmitcorrectentityaddressesandDUNSorFEInumber11CommonDataErrorsConsumerUseisdifferentthanPersonalUse–BaseCode130ForConsumerUseasaNon-FoodProduct–BaseCode100ForPersonalUseasaNon-FoodProduct–BaseCode210ForPersonalUseasHumanFood12FDFlagsFD1–IndicatesthatthearticlemaybesubjecttoFDAjurisdiction,includingFDAreviewunder801(a)oftheFD&CAct.
ForproductsnotsubjecttoFDAjurisdiction,afilercan"Disclaim"productfromFDAnotificationrequirements.
FD2–IndicatesthatthearticleisunderFDAjurisdictionandreviewofentryinformationbyFDAundersection801(a)willtakeplace.
However,thearticleisnot"food"forwhichpriornoticeinformationisrequired.
FD3–Indicatesthatthearticlemaybesubjecttopriornoticeundersection801(m)oftheFD&CActand21CFRPart1,subpartI.
,e.
g.
,thearticlehasbothfoodandnon-fooduses.
FD4–Indicatesthatthearticleis"food"forwhichpriornoticeisrequiredundersection801(m)oftheFD&CActand21CFRPart1,subpartI.
13FinalRuleTheFinalRuleforsubmissionofinformationtotheAutomatedCommercialEnvironment(ACE)waspublishedintheFederalRegisteronNovember29,2016.
14RemindersOptional–LineValueOptional–QuantityandUnitofMeasure–ExceptforRadiationEmittingProductssubjecttoaFormFDA2877,DeclarationforImportedElectronicProductsSubjecttoRadiationControlStandards–PriorNoticedatasetsMandatory–ImporterofRecordcontactinformationisrequiredforallnon-foodlinesAlthoughdataelementsmaybeoptional,transmittingthemmayexpediteprocessing15DRUGSMakingACEWorkforYou:ImportingFDARegulatedProducts16SubmittingDrugEntriesinACEKnowtheProductBeingImportedInformationNeededforSubmissionCommonReasonsforDrugEntryProcessingDelaysAdditionalResources17KnowtheProductBeingImported"Drug"isdefinedintheFood,Drug,andCosmeticActas,"articlesintendedforuseinthediagnosis,cure,mitigation,treatment,orpreventionofdisease"and"articles(otherthanfood)intendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals"[FD&CAct,sec.
201(g)(1)].
Thisincludes:Articlesthatarenotactiveingredients,butarelabeledwithaclaimto"diagnose,cure,mitigate,treat,orpreventdisease"18KnowtheProductBeingImportedExamplesofdrugproductsActivepharmaceuticalingredients(API)–boricacidpowderusedtomanufactureantisepticOver-The-Counter(OTC)–acetaminophenpainkiller(analgesic)PrescriptionDrugs(RX)–Dexamisole(anti-depressant)PharmaceuticalNecessities–inactiveingredients,excipients,intermediatesForResearchUseOnly–nottobeusedwithhumansandmaybeusedinanimalsInvestigationalUseOnly–willbeusedwithhumansoranimals19InformationNeededforSubmissionProgram&ProcessingCodesProgramCodefordrugcommoditiesisDRU.
TheProcessingCodewillbedeterminedbythecommoditysub-type:PG01-GovernmentAgencyCodeCommodityTypePG01-GovernmentAgencyProgramCodeCommoditySub-TypePG01-GovernmentAgencyProcessingCodeFDADrugsDRUPrescriptionPREFDADrugsDRUOvertheCounterOTCFDADrugsDRUPharmaceuticalNecessities,Containers,InactivePharmaceuticalIngredientsandExcipientsPHNFDADrugsDRUResearchandDevelopmentRNDFDADrugsDRUInvestigationalINV20InformationNeededforSubmissionProductCodeOverviewFDAProductCodeerrorsareamongthemostcommonreasonsforFDAEntryRejections.
UseavalidFDAProductCodepertheFDAProductCodeBuilder.
StructureoftheFDAProductCodePosition1-23456-7NameIndustryCode(N)ClassCode(A)SubClassCode(Aor"-")ProcessIdentificationCode–PIC(Aor"-")Product(AN)Legend:N–Numeric;A–Alphabetic;AN-Alphanumeric21InformationNeededforSubmissionProductCodesProductcodeismandatory.
*SubjecttoadditionalrulesbasedonFDAProgram/Processing/Productcodes.
SeePG02inindividualchaptersoftheSupplementalguide.
PG01:ProgramCode&CommodityPG01:ProcessingCode&CommoditySubtypePG02:IndustryCodeDRU–Drug*PRE-Prescription54,56,60,61,62,63,64,65,or66OTC-OvertheCounterRND-Research&DevelopmentINV-InvestigationalPHN-PharmaceuticalNecessities55,variouscodescouldapply22InformationNeededforSubmissionProductDescriptions,PackagingandConditionDataRequirementDrugsCommodityCharacteristicDescriptionMandatoryQuantityandPackaging*Optionalbutencouraged(ifentered,therulesfromtheSGmustbefollowed)PGALineValueOptionalbuthighlyencouraged*SeeAppendixDoftheFDASupplementalGuideforACEforvalidunitsofmeasureforDrugsPackagingContainers.
23InformationNeededforSubmissionIntendedUseCodes(IUC)andAffirmationsofCompliance(AoC)IUCismandatoryfordrugs.
OnlyIUCslistedinthechartcanbeusedfordrugs.
AoCrequirementsdependontheIUC.
IntendedUseCodesImportScenarioAffirmationsofCompliance080.
012Prescriptionhealthormedicalproductforhumanusethatisthesubjectofanapprovednewdrugapplication,abbreviatednewdrugapplication,orbiologicslicenseapplicationMandatory:REG,DLS,DAOptional:PLR100.
000ImportationforPersonalUse130.
000ForConsumerUseasaNon-FoodProduct–OvertheCounter(OTC)Mandatory:REG,DLSOptional:DA150.
007ActivePharmaceuticalIngredient/BulkDrugSubstanceforprocessingintoapharmaceuticalproductMandatory:REG,DLSConditional:DA150.
013ActivePharmaceuticalIngredient/BulkDrugSubstancetobeusedforPharmacyCompoundingMandatory:REG,DLS150.
017Importationofadrugcomponent(API)foruseinamedicalproductregulatedunderadevice(CDRH)applicationtype(e.
g.
,foruseinaPMA/510(k)drug-devicecombinationproduct)Mandatory:REG,DLSOptional:DA,LST,PM#,IDE24InformationNeededforSubmissionIntendedUseCodes(IUC)andAffirmationsofCompliance(AoC)IUCismandatoryfordrugs.
OnlyIUCslistedinthechartcanbeusedfordrugs.
AoCrequirementsdependontheIUC.
IntendedUseCodesImportScenarioAffirmationsofCompliance155.
009Importationofadrugconstituentpart(drugproduct)foruseinamedicalproductregulatedunderadevice(CDRH)applicationtype(e.
g.
,foruseinaPMA/510(k)drug-devicecombinationproduct).
Mandatory:REG,DLSOptional:DA,LST,PM#,IDE180.
009Chemicalforresearchanddevelopmentofapharmaceuticalproduct–subjectofanInvestigationalNewDrugapplication(IND),includingPlacebosMandatory:IND180.
017Chemicalforresearchanddevelopmentofapharmaceuticalproduct–laboratorytestingonly,nohuman/animaluse180.
018Chemicalforresearchanddevelopment;investigationaluseinanimals25InformationNeededforSubmissionIntendedUseCodes(IUC)andAffirmationsofCompliance(AoC)IUCismandatoryfordrugs.
OnlyIUCslistedinthechartcanbeusedfordrugs.
AoCrequirementsdependontheIUC.
IntendedUseCodesImportScenarioAffirmationsofCompliance180.
026FinisheddrugorAPIintendedforuseinaninvivobioequivalenceorbioavailabilitystudyinhumansthatqualifiesunder21CFR320.
31foranexemptionfromthePart312requirements;orfinisheddrugintendedforuseinclinicalinvestigationinhumansthatqualifiesforanexemptionfromPart312requirements.
920.
000USGoodsReturnedOptional:REG,DLS,DA,IND970.
000ImportforExport980.
000ForOtherUse:(APIsorFinishedDrugsnotelsewhereclassified)Mandatory:REG,DLS26InformationNeededforSubmissionEntitiesDUNSandFEIareoptional,butencouraged.
EntityRole(Code)EntityNameEntityAddressIndividualName,Tel#andeMailManufacturer(MF)MandatoryMandatoryShipper(DEQ)MandatoryMandatoryFDAImporter(FD1)MandatoryMandatoryMandatoryDeliveredtoParty(DP)MandatoryMandatoryFiler's/Broker'sPointofContact(PK)OptionalbutencouragedOptionalbutencouragedOptionalbutencouragedSponsor(New)–ifdifferentthanMForFD1(SPO)OptionalOptionalProducer(ProducerofAPI)(GD)OptionalOptional27InformationNeededforSubmissionOriginandArrivalDataRequirementDrugsCountryofProductionorCountryofSourceMandatoryCountryofRefusalMandatoryifrefusedbyothercountry(-ies)AnticipatedArrivalDateMandatoryAnticipatedArrivalTimeMandatoryAnticipatedPortofEntryOptional28SummaryKnowtheproductbeingimportedandassociatedrequirementsUnderstandthedataelementsProvidedcorrectandaccurateinformationGiveEntryFilerstheinformationtheyneedObtainallnecessaryinformationfromtheImporterNOTE:FDAwillnotbeabletoprocessanentrywithoutthisinformation.
YoucanhelpexpediteFDA'sreviewofyourimportedproduct(s)byinitiallyprovidingaccurateandcompleteinformationandbyrespondingquicklytorequestsfromFDAforadditionaldocumentsorinformation.
29CommonReasonsforDrugEntryProcessingDelaysEntryreviewprocessingdelaysoccurwhentherequirementsforsubmissionarenotunderstood.
FDAPREDICTlookupfailures:8.
03%ofAffirmationofComplianceCodesareincorrectlytransmittedfordrugproducts.
92%8.
0330AdditionalResourcesDrugApprovalsandDatabases:http://www.
fda.
gov/Drugs/InformationOnDrugs/default.
htmGuidance,Compliance,&RegulatoryInformation:http://www.
fda.
gov/Drugs/GuidanceComplianceRegulatoryInformation/default.
htmDrugFirmRegistrationLookup:http://www.
accessdata.
fda.
gov/scripts/cder/drls/default.
cfmDUNSNumberLookup:http://www.
dnb.
com/duns-number/lookup.
htmlNDCNumberLookup:http://www.
fda.
gov/Drugs/InformationOnDrugs/ucm142438.
htmNDA/ANDALookup:http://www.
accessdata.
fda.
gov/scripts/cder/daf/index.
cfmInactiveIngredientLookup:http://www.
accessdata.
fda.
gov/scripts/cder/iig/index.
cfmDrugApprovalProcess:http://www.
fda.
gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.
htmResearchUseOnlyLabeling:http://www.
accessdata.
fda.
gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.
cfmfr=312.
16031AdditionalResourcescontinuedInvestigationalNewDrugs(IND):http://www.
fda.
gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.
htmInvestigationalUseOnlyLabeling:http://www.
accessdata.
fda.
gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.
cfmfr=312.
6OTC(Nonprescription)Drugs:http://www.
fda.
gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209647.
htmOTCDrugLabeling:http://www.
accessdata.
fda.
gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.
cfmCFRPart=201NewDrugApplications(NDA):http://www.
fda.
gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.
htmAbbreviatedNewDrugApplications(ANDA):http://www.
fda.
gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.
htmPrescriptionDrugLabeling:http://www.
accessdata.
fda.
gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.
cfmCFRPart=20132INFORMATIONANDRESOURCESFORALLFDAREGULATEDPRODUCTSMakingACEWorkforYou:ImportingFDARegulatedProducts33AvoidingDelayswithFDADelaysoccurwhen:–Inaccurateinformationsuchasincorrectproductcodearesubmitted–IntendedUseCodequalifier"UNK"(Unknown)ToexpediteFDAreview:–Allinformationprovidedshouldbecompleteandaccurate–Provideconditionaldataelementsifapplicabletotheproductbeingdeclared–Provideoptionaldataelementssuchas:FEIand/orDUNSQuantityandUnitofMeasure34UsetheFDASupplementalGuideRevieweachofthePGrecordsuntilallrequiredinformationisunderstoodandhasbeenprovidedbytheimporterEachsectionidentifies:–mandatory,optional,andconditionaldataelements–codesandcodedescriptions–length/class(syntax)fordataelementtypesFollowanyinstructionsprovidedbyyoursoftwarevendortoensurealldataelementsareenteredfortransmission.
35SummaryKnowtheproductbeingimportedandassociatedrequirementsUnderstandthedataelementsProvidedcorrectandaccurateinformationGiveEntryFilerstheinformationtheyneedObtainallnecessaryinformationfromtheImporter36FrequentlyAskedQuestionQ:IfItransmitanFDAentry,doesACEallowmetocorrectthedataifIrealizeImadeamistakeA:WhenCBPreceivesanentry,itwillautomaticallysendtheentrytoFDAtoprocessinrealtimeiftheentryiswithinfivedaysofarrival.
UnlessCBPorFDArejectedtheentry,nocorrectionscanbemade.
IfCBPorFDAdidrejectyourentry,workwithyourABIrepresentativetosendacorrection.
37FrequentlyAskedQuestionQ:WhendoesFDAreceivetheentrydatafromCBPIhavehadan"FDAReviewMessage"forseveraldays.
A:OncetheentryisacceptedbyCBP,CBPsendsoutagenericmessagethatsays"DATAUNDERPGAREVIEW.
"ThisisnotaconfirmationthatthedatawassenttoFDA.
CBPwillonlysendtheentrytoFDA,ifthetransmittedarrivaldateiswithinfivedays.
Ifitismorethanfivedaysout,CBPwillwaituntilitiswithinthattimeframetosendittoFDA.
IfitiswithinfivedaysofarrivalandyouhavenotreceivedanyFDAresponsewithinyourusualturnaroundtime,contactFDA'sACEHelpDeskatACE_Support@fda.
hhs.
govandyourCBPClientRepresentative.
38FrequentlyAskedQuestionQ:DoesFDApreferDUNSorFEInumbersforentityidentificationcodes(PG19)A:FEIandDUNSareoptional,butencouraged.
Note:Asof5/30/2017,theDUNSwillberequiredfortheFSVPimporterforeachlineentryoffood,unlesstheyaresubjecttoexemptionand/ormodifiedrequirements.
Foradditionalinformation,visithttps://www.
fda.
gov/Food/NewsEvents/ConstituentUpdates/ucm549668.
htm.
39FrequentlyAskedQuestionsQ:IstheDrugRegistrationnumberanFEInumberA:TheDrugRegistrationNumber(REG)isthe9-digitDUNSnumberthefirmhasonfilewithFDACenterforDrugs,Evaluation,andResearch(CDER)DrugRegistration(eDRLS).
OnlythoseDUNSnumbersonfilewitheDRLSareDrugRegistrationNumbers(REG).
ThesecanbefoundatontheDrugFirmRegistrationLookupwebpage:http://www.
accessdata.
fda.
gov/scripts/cder/drls/default.
cfm40FrequentlyAskedQuestionQ:Whycan'tIseethestatusofmyentryinITACSWhydoesitsay"FDAentrystatusinformationisnotavailablependingreceiptofconveyancearrivalnotification"whentheshipmenthasarrivedA:CBPisnotconsistentlysendingarrivalnotificationstoFDAuponarrivalofashipment.
Withoutreceiptofthatnotification,ITACSwilldisplaytheabovemessage.
Thisdoesnotaffecttheabilitytosubmitdocuments,submitavailabilityinformation,orFDA'sabilitytoreviewtheentry.
Reference:CSMS#16-00100341FrequentlyAskedQuestionQ:WhatarethelessonslearnedforhowACEchangedfilingforFDAA:CommunicateearlyandoftenaboutFDArequirements.
(Importer,Broker,andSoftwareVendor).
Delaysandrejectsoccurwheninaccurateinformationisprovided,suchasinvalidproductcodeoranunknownintendedusecode.
UseFDAasaresource.
Attendwebinarsorrequestatrainingsession.
Weareheretohelp.
42FrequentlyAskedQuestionsQ:Is"UNK"(Unknown)stillallowedasanIntendedUseCodeA:UNKisstillallowedasanIntendedUseCodewhentheIUCismandatory.
If"UNK"isdeclared,CBPwillnotrejecttheentryifAffirmationsofCompliancearenotprovided.
FDAhighlyencouragesthetransmissionofcompletedata,includingthecorrectIntendedUseCodeandAffirmationsofCompliance.
RefertotheFDASupplementalGuideforafulllistofrequirementsbasedontheimportscenario.
UNKshouldonlybeusedifinformationisnotabletobeobtained.
UtilizingthiscodemayleadtomanualreviewsanddelayedprocessingbyFDA.
43ResourcesCSMS#16-000557,FDAACEEntries:CommonErrorshttps://csms.
cbp.
gov/viewmssg.
aspRecid=21913&page=&srch_argv=16-000557&srchtype=&btype=&sortby=&sby=CSMS#16-000741,FDAACERejectDocumentPostedtoFDA.
govhttps://csms.
cbp.
gov/viewmssg.
aspRecid=22092&page=&srch_argv=16-000741&srchtype=&btype=&sortby=&sby=44ResourcesAvailableOnlineFDAACEAffirmationsofComplianceandAffirmationsofComplianceQuickReferenceathttp://www.
fda.
gov/forindustry/importprogram/entryprocess/entrysubmissionprocess/ucm461234.
htmFDAACE/ITDSWebpage(includingFDASupplementalGuide)athttps://www.
fda.
gov/industry/import-systems/automated-commercial-environmentinternational-trade-data-system-aceitdsFDADUNSPortalathttps://fda.
dnb.
com/FDAUI/login.
aspxandFDAGuideathttps://www.
fda.
gov/media/95828/downloadProductCodeBuilderToolandTutorialathttps://www.
accessdata.
fda.
gov/scripts/ora/pcb/index.
cfmFormoreinformationaboutFDA'sImportProgram,visithttp://www.
fda.
gov/forindustry/importprogram/default.
htmForinformationaboutACEQuantityDataInstructions,visithttps://www.
fda.
gov/downloads/ForIndustry/ImportProgram/EntryProcess/ImportSystems/UCM487256.
pdf45ResourcesContacttheFDAImportsInquiryTeamforquestionsregardingFDAimportoperationsandpolicy,productcoding,FDflagsassociatedwithHTScodes,entrydeclarationrequirementsfordeterminingadmissibility,ifaproductisregulatedbyFDAandothergeneralimportquestions.
FDAImportsInquiry@fda.
hhs.
gov301-796-035646ResourcesContactFDAACESupportCenterfortechnicalquestionsrelatedtotheFDASupplementalGuide,requireddataelements,ACEentries,rejects,anderrors.
ACE_Support@fda.
hhs.
gov877-345-1101(domestictoll-free)571-620-7320(localorinternational)CSMS#17-000162:TheACESupportCenteroperatesfrom6a.
m.
to10p.
m.
ESTsevendaysperweek.
AlwayskeepyourCBPClientRepresentativeonallACE-relatedemailtraffic47FDAPointsofContactforImportsFDAUnitContactInformationAreasofFocusACESupportCenterACE_Support@fda.
hhs.
govTollFree:877-345-1101Local/International:571-620-7320TechnicalissuesrelatedtotheFDAsupplementalguide,requireddataelements,andgeneralACEsubmissionquestions,includingentrysubmissionsrejectedbyFDA.
FDAImportsInquiryFDAImportsInquiry@fda.
hhs.
gov301-796-0356GeneralquestionsregardingFDAimportoperationsandpolicy,includingproductclassification(program,processing,productandHTScodes)anddeclarationLocalFDAOfficehttp://www.
fda.
gov/ForIndustry/ImportProgram/ucm319216.
htmFirst-linesupportforproductcodingandentry-specificquestions,includingworkingthroughtheFDAentryadmissibilityprocess,oncetheentryissuccessfullytransmittedtoFDAandacceptedDivisionofFoodDefenseTargetingPrior.
Notice@fda.
hhs.
gov866-521-2297http://www.
fda.
gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006836.
htmGeneralquestionsregardingPriorNoticeforfoodshipments48Questions