FDA WARNING_LETTER - Pierre Fabre Medicament Production - September 08, 2009

This FDA Warning Letter, dated March 26, 2010, was issued to Pierre Fabre Medicament Production - Aquitaine Pharm International 2 following an inspection from September 1-8, 2009. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm's September 29, 2009, response was deemed insufficient.

Key violations include: 1. **Failure to thoroughly investigate unexplained discrepancies (21 CFR § 211.192):** * Aloxi (Palonosetron HCl) injection batches failed yield limits, with no identified root cause for high particle content or impact assessment. * Uninvestigated out-of-limit (OOL) in-process fill weight results for validation batches, with inconsistent fill weight specifications. * Inadequate investigation of OOL non-viable particle counts in critical areas during validation, with a new procedure implemented post-manufacturing. * Failure to investigate critical defects (particles) found during self-check visual inspections after multiple automated and manual inspections, indicating inadequate control. 2. **Failure to establish and follow written procedures for in-process controls (21 CFR § 211.110(a)):** High vial