FDA Criticises Root Cause Investigations at EU Facility

In October 2024, the U.S. FDA inspected NWL Netherlands Services B.V. and issued a Warning Letter citing serious GMP violations. The facility reported seven out-of-limit (OOL) microbial events in a key drug component system—some exceeding 10,000 CFU/mL. Despite the risks, investigations were narrow, focusing only on nearby test dates and relying on final product tests to justify continued production.

The FDA deemed the response inadequate, noting a lack of thorough root cause analysis, CAPAs, and retrospective risk assessment. Planned improvements—such as quality team training and impact assessments—were considered insufficient without supporting documentation.

The FDA now demands an independent review of the company’s investigation process and a detailed corrective action plan to strengthen root cause evaluations, CAPA effectiveness, and quality oversight. This case highlights the critical need for comprehensive investigations, especially in recurring quality failures.

18-06-2025