FDA Warns California Firm Over Inadequate Root Cause Analysis and CAPA

The U.S. FDA has issued a Warning Letter to a California-based company for major lapses in Root Cause Analysis and Corrective and Preventive Action (CAPA). Similar to recent enforcement actions, the agency cited the firm for failing to identify true root causes, implement effective CAPAs, or assess broader product impacts—signalling deep flaws in quality oversight. The Quality Unit (QU) neglected to investigate multiple out-of-specification results, including API identity tests, microbial contamination in the water system, and stability failures in released batches. FDA noted that investigations lacked scientific justification and supporting documentation, and CAPAs were insufficient or delayed. The agency urged the company to hire a CGMP consultant to address systemic quality issues, reminding executive management of its ultimate responsibility for compliance.

27-10-2025