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1、RegulatoryProceduresManual–July2012Chapter7RecallProcedures___________________________________________________________________________Chapter7RECALLPROCEDURESThischaptercontainsthefollowingsections:SectionTopicPage7-1PURPOSE......................................
2、.......................................................................7-17-2BACKGROUND.....................................................................................................7-17-3SUMMARYOFFDARESPONSIBILITIESANDPROCEDURES..........................7
3、-27-4RECALLENTERPRISESYSTEM.........................................................................7-37-5INITIATIONOFARECALL....................................................................................7-47-6RECALLCLASSIFICATIONANDSTRATEGY................
4、...................................7-127-7NOTIFICATIONSANDPUBLICWARNING........................................................7-157-8MONITORINGANDAUDITINGRECALLEFFECTIVENESS.............................7-207-9RECALLTERMINATION...................................
5、..................................................7-267-10ATTACHMENTS,EXHIBITS,ANDAPPENDIX...................................................7-277-1PURPOSEThischapterprovidespolicy,definitions,responsibilities,andproceduresforagencyunitstoinitiate,review,classif
6、y,publish,auditandterminaterecallactions.Itimplements21CFRPart7SubpartC–Recalls(IncludingProductCorrections)–GuidelinesonPolicy,Procedures,andIndustryResponsibilities.(SeealsoInvestigationsOperationsManual,Chapter8,RecallActivities.)7-2BACKGROUNDRecallsareanappr
7、opriatealternativemethodforremovingorcorrectingmarketedconsumerproducts,theirlabeling,and/orpromotionalliteraturethatviolatethelawsadministeredbytheFoodandDrugAdministration(FDA).Recallsaffordequalconsumerprotectionbutgenerallyaremoreefficientandtimelythanformal
8、administrativeorcivilactions,especiallywhentheproducthasbeenwidelydistributed.Manufacturersand/ordistributorsmayinitiatearecallatanytimetofulfilltheirresponsibilityto
