FDA历年检查483警告信汇总-中英

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1、：FDAWarningLetters,Form483ObservationsandEstablishmentInspectionReports–PreviewFDA警告文字，来自483观测资料和预先检查报告。Important:WarninglettersandotherFDAinspectiondocumentationshouldbeinterpretedinthecontextoffullcontent.Justlookingatextractsmaybemisleading.AndsometimestheyincludegoodadvicefromtheFDAnotment

2、ionedintheextracts.重要性：警告文字和其他的FDA检查文件必须说明，根据上下文包括全部内容。仅是看摘录可能被误解。并且有时要包括从FDA那里征求好的建议，而不是只提到摘录。FDA483InspectionalObservations,EIRs&WarningLetters-PreviewkeywordsandexcerptsTypeContent&deviationsKeywords,selectedexamples(notcomplete).Clickon"D"toview,printand/ordownloadthefileswithfulltext.(Int

3、hisPreviewModetheclickwilllinkyoutotheorderform)Tellyourfriendsaboutthispage!FDA检查报告，EIRS和警告文字-预览关键词和摘录。类型内容和目录关键词，选择事例（不用完整）尽力画出“D”来观察、印刷和/或下载所有文件的全部内容。（在这部分预览方式中，CLICK将使你形成定货表格。）D483Keywords:Watersystems,diagrams,processvalidation,cleaningvalidation,batch85itemsrecordreview,training,instrume

4、ntcalibration,reservesamples,testing,productspecification,distributionrecords,analyticalmethod,USPstandard,failureinvestigation,labeling,SOPs483关键词：水系统，图表，过程确认，清洁确认，一批记录：有回顾，培训，仪表校正，储备样本，检测，制品技术规格，分析方法，W-156USP标准，故障调查，标签，SOPS。Primarydeviations:missingdiagrams,noinstallationqualification,noop

5、erationqualification,nobatchrecordreview,inadequateGMPtraining,inadequateequipmentcalibration,inadequatestorageofreservesamples,SOPsnotapproved,inadequateproceduresforsamplingandtestingExamples:-Therewasnodiagramofthewatersystem-BatchrecordsnotreviewedbyQC,-Routinecalibrationnotperformedaccor

6、dingtoawrittenprogram-ConductivitymetersnotcalibratedtoanNISTtraceabledevice-Batchrecordslackadescriptionofnameoftheequipment-Noreferenceinanalyticalmethodtorecognizedstandardmethod.-CurrentSOPsnotreviewedandapprovedbyQCUW—156。主要错误：缺少图表，无安装资格，无操作资格，无回顾记录，GMP培训不充分，设备刻度不清楚，储备事例不充分，SOP没被证明，取样和检测程

7、序不充分。事例：-水系统没有图表-大批记录没有被质控回顾-常规表格没有根据书面程序执行-电导计没有根据NIST可追踪装置校准-大批记录缺少设备描述名字-没有根据分析方法涉及可识别的标准方法-当前SOPS没有被QCU回顾和验证483Keywords:Electronicrecords,electronicsignatures,Part11,Equipmentcalibration,Dequipmentqualification,certificateofanalysis