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FDA Urges Device Manufacturers To Double-Check Their CAPA Systems

This article was originally published in The Silver Sheet

Executive Summary

WITH CORRECTIVE AND PREVENTIVE ACTION CITATIONS consistently showing up in FDA-483 forms and warning letters, the agency is urging medical device manufacturers to ensure that they are complying with all of the CAPA requirements in the Quality System Regulation. FDA experts offer tips on performing adequate complaint investigations, integrating risk management into the CAPA system, and performing adequate verification and validation of a corrective action... FROM WRITING GUIDANCES TO ANSWERING INDUSTRY CALLS, a workday at FDA’s device center is never routine. Compliance Officer Cap Uldriks tells how staff ensure projects get done...

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