The United States Food & Drug Administration requires under Title 21 of the Code of Federal Regulations (21 CFR) Part 820.100, that medical device manufacturers must establish a system to address Corrective And Preventive Actions (CAPAs) to meet regulatory standards. This article provides insight into medical device quality issues relating to CAPA through the evaluation of warning letters issued by the US Food and Drug Administration (FDA) between 2013 and 2022. The results of this study indicate that despite the medical device regulations being in place since 1976 violations of 21 CFR 820.100 (CAPA related violations) continues to be a significant issue for medical device companies.
Original languageEnglish
Article number397
Pages (from-to)1-4
Number of pages4
JournalPharmaceutical Regulatory Affairs: Open Access
Issue number6
Publication statusPublished - 8 Nov 2023


  • CAPA


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