Warning: Your “Check CAPA” Light is On - FDA Form 483

Warning: Your “Check CAPA” Light is On | Ask Cato:

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.

"The requirements are summarized as follows:

1. Analyze processes to identify the root cause of the nonconformance and to proactively identify potential causes of future nonconformance;
2. Investigate the cause;
3. Identify actions needed to correct and prevent nonconformance recurrence;
4. Validate that the CAPA is effective and does not cause unintended adverse effects;
5. Implement and record changes in procedures to correct and prevent the recurrence of noncompliance;
6. Ensure direct dissemination of CAPA information to those responsible for assuring product quality to ensure adequate training for preventive actions; and
7. Submit the relevant documentation on CAPA for management review."

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