FDA Flags Recurring Failures in Root Cause Analysis and CAPA

Recent FDA Warning Letters to Apotex Inc. and Scientific Protein Laboratories (SPL) reveal persistent industry gaps in root cause analysis (RCA) and CAPA effectiveness. At Apotex, repeated leak-test failures led to “testing into compliance,” where staff retested until passing results appeared instead of investigating true causes. FDA also criticised delayed action on a high-risk packaging incompatibility and failure to expand investigations to all affected batches. Additional concerns included poor aseptic conditions, damaged equipment and weak environmental monitoring.

At SPL, the FDA noted that revised procedures still failed to ensure rigorous investigations. Root causes were insufficiently defined, scopes remained narrow and CAPA evidence was lacking, prompting FDA to require an independent review.

Together, these letters highlight key expectations: stop re-testing to mask failures, broaden investigations, act quickly when risk is high and strengthen quality oversight to ensure CAPAs address systemic problems rather than symptoms.

17-11-2025