Warning Letter: Failure to establish procedures (ucm224014)

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Ofni Systems

Failure to establish and maintain adequate procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, no protocol, including acceptance criteria, was established for the validation of Change Request [redacted]. Additionally, there was no documentation showing that this change was validated.

View the original warning letter.


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