US FDA Deviation, CAPA, and investigation findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

You failed to take adequate corrective action preventative action (CAPA) for a manufacturing system, resolution of an aberrant condition in a timely manner.

Quality oversight of deviation management is inadequate.

Failure to perform a thorough investigation of an unexplained discrepancy.

There is no documentation of the revalidation of a process performed in response to changes or process deviations.