FDA WARNING_LETTER - Multaler Et Cie S.A.S. - April 17, 2024

The FDA issued a Warning Letter to Multaler et Cie SAS, FEI 3010165406, following an inspection from April 15-17, 2024, at their Argenteuil, France facility. The letter, dated November 5, 2024, details significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug product adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components for identity and conformity (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm failed to adequately test incoming components like propylene glycol, glycerin, and octocrylene for identity, and relied on supplier Certificates of Analysis (COAs) without validating their reliability. This includes not performing USP identity testing for DEG/EG in high-risk components. The firm's response was inadequate, lacking a detailed plan, timeline, and retrospective review. 2. **Failure to establish adequate laboratory controls (21 CFR 211.160(b))**: The firm did not demonstrate that chemical and microbiological test methods were appropriate to assure product quality. Their response was inadequate, lacking details on microbiological method improvements, chemical method validation timelines, and retrospective review of previously distributed products