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FDA Inspection Summary FDA审核纪要(英文).docx

2024-10-24

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2013.4.23FDAInspectionSummary Twoforms Routineinspection 目的名称的（为了投诉而来） TheFDACometh AnOverviewofHowtoHandleFDAInspection FrontInspection-veryimportant Theyestablishasenseoforganization’s -professionalism -presentation -efficiency TheReceptionisakeyfirstcontact. -AproceduretoreceivetheFDAmustbeinplace. -Theymustknowhowtocontact -Havethemwaitifthecontactisnotimmediatelyavailable. Receivingtheinspector -ManagementRep&GM -Checkthedetails -Receivenoticeofinspector(FDA-482) “Wecannotsayno.” -SignatureonFDA482 -Businessleader,orplantleader -Determineagenda(QSITArea?) Qualitysysteminspectiontechnique -Identitydurationofinspection OverviewPresentation Organization Roles&Responsibility Facilityinfo Policies -Photos,video,taperecorders(no) -Samples -Requirementstoaccompany/investigatoratalltime. TourofWarehouse Whatweresomeoftheproblems?(video) GuessingatSOPs Ifyoudon’tknowananswer,nottomakeanoteandgetanswerfromsomeonewhoknows Leftinvestigatoralone Flipremarks随意评论/nosenseofhumor/bodylanguage,eyecontact,professionalandconfident Notimmediatelyaddressingthingthatcouldbeearlycorrected Accesstocompanyrecords Don’tallowfreeaccesstodocs. RecordsFDAisnotallowedto Providedocsoneatatime Makeasampleandrecord Thetourofmanufacturing Answerthequestionasked Don’tvolunteerinfo. Don’tvolunteertomakecorrections. -Requestsforsamplewillbehandledbytheinspectoraskedfor -AlwaystakeaduplicateofFDAsample -Requeststosignreceipts,affidavits,etc,arereferredtoGM Whatweresomeoftheproblems?(Video) Failuretofollowrecordkeepingprocedures “Cleaningupthedata”-YIKES! Failfyingdata -Triedtodivertattention企图转移 -Requesteddiscussioninfrontofinvestigator TheExitInterview每日总结 -Dailydebriefingshelpavoidsurprises -Usethesetofollow-uponopenrequests -Clarifyinfo -Bringoutsituationswhereinvestigatormadeanerrorinobservation -TheinvestigatorpresentstheFDA-483findings,ifany -Askifthereareanyopenquestions -Askifinvestigatorisdissatisfiedwithanyanswerreceived -Thisisyourlastchancetoamendtheobservation TheFD

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