Are you verifying the effectiveness of your CAPA?

Are you performing the verification in a timely manner?

A company recently received this 483 observation: 

…..Corrective and preventive action activities and/or results have not been adequately documented.

Specifically, on reviewing 17 Corrective and Preventive Action (CAPA) records spanning over the last 2 years, I observed that 12 closed CAPA records out of the 17 records reviewed lack effectiveness verification. In addition, 2 of the CAPA records that were initiated 3 years ago are still open. Your Chief Operating Officer when queried on the subject confirmed the observation and stated that you neither verify nor validate corrective and/or preventive actions. This is contrary to both CAPA regulatory requirements and your CAPA procedure.

For more observations pertaining to medical device controls see Issue 1021 available today.  It also has observations pertaining to manufacturing controls, laboratory controls and packaging and labeling controls.

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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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