GuidancefbrIndustryCircumstancesthatConstituteDelaying,Denying,Limiting,orRefusingaDrugInspectionFDA行业指南-药品现场检查中被认为是延迟、否认、限制或拒绝的情形I>TRODUCTIONOuJuly9.2012.theFoodandDrugAdiiuiiistratioi]SafetyandIiuio^ationAct(FDASIA)(PublicLaw112-144)wassignedintolaw.Section70,ofFDASL\adds501(j}totheFood.Drug,andCosmeticAct(FD&CAct)todeemadulteratedading(lu)tdiasbeeninaniifacnued,piocessed.packed,orheldinanyfactor>p.warehouse,orcstiiblisluiieiitand(Ikowner,opeiatoi.orasentofsuchfactoiy.warehouse,orestablisluneiitdelays,denies,oilimitsaninspection,orjeftise^top^nnitstryorinspection."Secfiou^0_(b)ofFDASL\reqiiii滔rheFoodan
tigatorhasnotcompletedsuchTraining.企业不准FDA检查官进入无菌工艺区域，直至检查官符合企业的无菌更衣程序。企业职业安全和健康管理部门要求任何人在进入厂房的某些特定区域时必须经过
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，而FDA检查官没有完成这样的培训。B、限制拍照PhotogiaplisareanintegralpanofanFDAinspectionbecausetheypresentanobjectn'eandconteuipoiaiieousrepiesentationoffacilityconditions.Examplesofconditions01practiceseffectivelydociuiientedbyphotogiaplisinclude,butarenotliiiiitedto:evidenceofrodentsorinsectiiifestaTioii:fault)coustinctionoiniaiiitenaiKeofequipmentorfacilities:productstorageconditions:productlabelsaudlabeling:and.visibleconraniiiiatiouofrawmateiialsoiiiiiisliedproducts.ImpedingorlesistingphotographybyanFDAiinestigatormaybeconsideredaliiiiitarionifsuchphotographsaredeteroiLiiedbytheiiivesrigatoitobenecessaiyroeifecti\elycondiTcrtliarpaniciilarinspection,Ajiexampleofapotentiallyreasonableexplanationtliatuiiglitresultillthedrugsnotbeingdeemedadulteratedimdei'section501(j)oftiieFD&CActincludes,butisnorlimitedto:♦Hieclieinicalpiopeitiesofproductsinamiiactmedatdieihcilityaiesuchthattakingpliotogiapliswouldad^erselyaffectprodiKtquality.FDA检查官可以使用拍照取证，如果企业组织其拍照将被认为该产品是假劣药品，除非有下列理由，包括但不仅限丁：由丁产品的特殊化学性质，拍照将会对产品的质量产生影响C、限制查看和/或复制记录记录限制包括但不仅限丁：AfacilityrefiisestoallowrheFDA[iiivesrigarortoreviewrhefacility'ssliippiiiarecordsthatFDAhasautboritytoinspect.Afacilityproxidessome,butnotallofltherecordsrequestedbytheFDAiiKestigatorthatFDAliasauthoritytoinspect,AfacilityprovidestheFDAiinestigatorrherequestedrecordsthatFDAhasaurliorihr-tomspect.bintheyareunreasonablyredacted.11Afacility-lefiisestoprGiiderecordsTharFDArequestspiirsiianttosection三04(a“4)h01suchiccoidsareumeasoiiablvredacted.企业拒绝FDA检查官查看其有权检查的产品货运记录。企业只提供了FDA检查官有权查看的部分记录，而不是全部。企业提供了FDA检查官要求查看的记录，但是这些记录没有合理编辑*。企业拒绝提供FDA检查官要求查看的记录，或这些记录没有合理编辑。*:没有合理编辑是指删除信息或模糊信息。D、限制或阻止采样Colkctiiigsamplesis□criticalpartofFDA'sinspectioualandregulatoiyacriviTLes.SectionPZ(角)oftheFD&CAcrgivesFDAau比onlytoconductmvestigarionsiandcollectsamples.PreventinganauthoiizedrepiesentativeoftheFDAiiomcollectingstamtorilyaiiTiionzedsampksmaybeconsideredlimitingtheinspection.Examplesofsamplelimitationinclude,burarehotlimitedto.decliningtoalloworimpedingFDATocollectthefollawinstypesofsamples:enviromneiHalsampler,fiinshedproductsamples,rawmaterialsamples,in-processm^rehalsamples,andiesenesamplesinbioeqiiivalenceandbioanalexicalstudies.采样取证是FDA检查的一个重要手段。企业阻止其采样被认为是限制检查，这样的例子包括但不仅限丁FDA采集下歹0样品：环境样品、成品、原材料样品、中间体，以及生物等效性和生物分析研究中的留样。4、拒绝进入或检查这样的例子包括但不仅限丁：Withoutreasonableexplanation,thefocilitybarsTheFDAiiivestigatorfromeineiiiigtheihcility01ceiiaiiiareasoftheiacilityby.ibrexample,notunlockingTheareasortakingorliernecessaiyactionsTharwouldpeniiitaccessbyrheitnestigator.FollowingFDA'sattempttocontactthefacility'sdesignatedcontacr(s)toscheduleanuisijectiou.thefacilityfailstorespond.T】虻facilitydoesnotanswercallsfiomtheFDAiiKesrigatoiwhoispieseniattliefacility,despiteclearevidenceofthepresenceofemployeesengagedii)job-ielateclftmcTions.没有合理的解释，企业通过锁门或其他行为禁止FDA检查官进入厂房或厂房的某个区域。FDA联系不上企业指定的联系人来沟通检查安排事宜，企业不能给出解释。企业没有回答进行现场检查的FDA检查官提出的问题，尽管有证据
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