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  • Warning Letter: Failure to validate CAPA effectiveness (ucm250065)

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    Ofni Systems

    Failure to adequately verify or validate that the corrective and preventive action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). …. design changes were approved, but no validation or verification activity evaluating the effectiveness of the corrective action was performed or documented. Failure to validate an automated data processing system used as part of the quality system, as required by 21 CFR 820.70(i). For example: a. The CPRPlus database used from 2006 to the present to track AEDs and conduct audits of tracked AEDs was not validated.

    View the original warning letter.


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