FDA WARNING_LETTER - Biomerieux Inc - July 30, 2014

On July 14-30, 2014, an FDA inspection of BioMerieux SA's Hazelwood, MO facility revealed significant deviations from Quality System Regulations (21 CFR Part 820) for medical devices, rendering products adulterated.

Key violations include: 1. **Inadequate Complaint Handling (21 CFR 820.198(b)):** 18,926 complaints with component replacements lacked thorough investigation into failure causes (design, production, supply, assembly), and 6,861 complaints had no documented investigation or justification for not investigating. The firm's responses were deemed inadequate, failing to address retrospective analysis of component failures or adherence to their own complaint-handling procedures. 2. **Inadequate Control of Nonconforming Products (21 CFR 820.90(a)):** 39 production hardware failure non-conformances grouped different failure modes under one report, hindering trend analysis. The firm's response was inadequate, failing to address root cause investigation for these or the approximately 2,443 non-conformances since the last inspection. 3. **Inadequate CAPA Procedures (21 CFR 820.100(a)):** Complaint trending using undefined error codes and non-conformance trending by component instead of specific failure modes were inadequate. Responses were insufficient, with proposed corrective actions having excessively long