FDA and EU Authorities Crack Down on Poor Root Cause Analysis in Pharma Industry

Regulatory agencies, including the FDA and the Spanish Agency of Medicines and Medical Devices, are tightening oversight on root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) for deviations and out-of-specification (OOS) results.

FDA Warning Letter to Chem-Tech Ltd (USA)

The FDA cited Chem-Tech Ltd for:

• Inadequate investigations into OOS results from an external lab.
• Lack of proper CAPA measures to address issues.
• Deficient procedures for handling deviations and complaints.

EU Non-Compliance Statement (EudraGMDP Report No: PE010-4529)

A Spanish manufacturer was flagged for:

• Poor management of deviations, OOS, and OOT results.
• Failure to implement effective CAPA.

Regulators emphasize thorough RCA and CAPA implementation to ensure GMP compliance, product quality, and patient safety. Manufacturers must strengthen these processes to avoid penalties.

22-04-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition