FDA Warning Letter: CAPA not only needed for Deviations

The US FDA has issued a Warning Letter highlighting recurring weaknesses that can arise in any organisation if CAPA processes are not consistently implemented and enforced. In this Warning Letter OOS investigations and changes/edits in electronic systems were not adequately addressed. The tone of the letter is clear: when results are failing or data are being modified, FDA expects scientifically sound investigations, robust CAPA, complete documentation, and effective QA oversight. 

FDA cited failures to investigate OOS results and emphasized that the firm's CAPAs were "not robust" because OOS assay stability failures continued despite multiple actions.  The firm attributed stability failures to "product behavior," which FDA considered not scientifically sound, particularly when a test method change produced different outcomes.

FDA expected the investigation to assess whether the analytical method contributed to variability and why method validation did not detect limitations earlier. FDA also described an example where an OOS result was invalidated because of a "solution preparation error" without conclusive evidence, with inadequate documentation and no CAPA for analyst training.  Furthermore, the insufficient evaluation of other batches was criticised.

FDA also cited the Quality Unit for lacking controls to "assure the integrity of electronic batch record data", including a case where a QA employee instructed a software vendor to make EBR changes that "were not captured in the audit trail" or managed through the quality system. 

FDA states that even if the intent is to correct inaccuracies, this should have been documented and managed as a deviation, including "an assessment of communications with other software vendors". FDA now expects appropriate CAPA reports, impact assessments and effectiveness checks for the CAPAs.