The Top 15 Medical Device Deficiencies Cited by FDA in 2014

The number of 473s issued (972) marked the first year since FY 2008 that FDA has issued fewer 483s than the year prior, and is the least issued since FY 2010 when FDA issued 976.

The Top 15 Medical Device Deficiencies in FDA’s 483 Reports:  FDA’s inspections also noted common deficiencies at medical device manufacturers.
Regulatory CitationShort DescriptionLong DescriptionFrequency
21 CFR 820.100(a)Lack of or inadequate proceduresProcedures for corrective and preventive action have not been [adequately] established.360
21 CFR 820.198(a)Lack of or inadequate complaint proceduresProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established. Specifically,***251
21 CFR 820.50Purchasing controls, Lack of or inadequate proceduresProcedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.129
21 CFR 820.75(a)Lack of or inadequate process validationA process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.122
21 CFR 803.17Lack of Written MDR ProceduresWritten MDR procedures have not been [developed] [maintained] [implemented].117
21 CFR 820.100(b)DocumentationCorrective and preventive action activities and/or results have not been [adequately] documented.101
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate proceduresProcedures have not been [adequately] established to control product that does not conform to specified requirements.100
21 CFR 820.30(i)Design changes – Lack of or Inadequate ProceduresProcedures for design change have not been [adequately] established. Specifically,***95
21 CFR 820.22Quality audits – Lack of or inadequate proceduresProcedures for quality audits have not been [adequately] established.90
21 CFR 820.198(c)Investigation of device failuresComplaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary.68
21 CFR 820.25(b)Training – Lack of or inadequate proceduresProcedures for training and identifying training needs have not been [adequately] established.61
21 CFR 820.40Procedures not adequately established or maintainedDocument control procedures have not been adequately [established] [maintained]. Specifically,***61
21 CFR 820.20(c)Management review – Lack of or inadequate proceduresProcedures for management review have not been [adequately] established. Specifically,***60
21 CFR 820.181DMR – not or inadequately maintainedA device master record has not been [adequately] maintained.58
21 CFR 820.80(d)Lack of or inadequate final acceptance proceduresProcedures for finished device acceptance have not been [adequately] established.55

REFERENCE:  RAPS Regulatory Focus; 08 DEC 2014; Alexander Gaffney, RAC

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