BR SAS – FDA Warning Letter, Sep 22, 2017

The FDA issued a Warning Letter to Biologique Recherche (B.R.) SAS following a September 18-22, 2017, inspection of their Suresnes, France drug manufacturing facility, citing significant CGMP violations. The FDA found the firm's drug products adulterated due to non-conforming manufacturing methods, facilities, or controls. The company's October 13, 2017, response was deemed inadequate.

Key violations include: 1. **Failure to test drug products:** The firm released OTC drug products without adequate testing for identity and strength of active ingredients (21 CFR 211.165(a)). 2. **Failure to test components:** Incoming raw materials were not tested for identity, purity, or strength; the firm relied on unqualified supplier COAs (21 CFR 211.84(d)(1) and (2)). 3. **Inadequate quality control unit procedures:** The firm lacked written procedures for numerous quality unit functions, including deviation investigations, annual product reviews, OOS results, and batch record management (21 CFR 211.22(d)). 4. **Inadequate stability testing:** The firm lacked sufficient stability data to demonstrate drug product quality throughout their expiry (21 CFR 211.166(a)). 5. **Unvalidated manufacturing processes:** Production processes were not