FDA Warns Companies Over Inadequate Root Cause Analysis and CAPA Failures

Recent FDA Warning Letters highlight ongoing deficiencies in root cause analysis and corrective and preventive action (CAPA) management, particularly in response to deviations and out-of-specification (OOS) results. Four recent letters, covering one company in India and three in the U.S., underscore systemic quality oversight failures.

Hikal Limited (India) failed to adequately investigate 22 complaints of metal contamination in active ingredients. Investigations did not assess equipment suitability, cleaning procedures, or in-process controls, resulting in ineffective CAPAs. The FDA requested a comprehensive, independent review of their deviation, complaint, and OOS investigation systems.

Wisconsin Pharmacal Company released rejected drug units without proper investigation, and microbial deviations, including Staphylococcus aureus contamination, were inadequately addressed. Somerset Therapeutics and Columbia Cosmetics also failed to thoroughly investigate discrepancies or OOS results, implement effective CAPAs, or prevent recurrence.

The FDA emphasizes that inadequate root cause analysis and incomplete CAPA systems can result in recurring quality issues and regulatory enforcement actions.

26-09-2025