FDA WARNING_LETTER - BBCOS srl - June 23, 2017

The FDA inspected BBCOS srl's drug manufacturing facility in Cherasco, Italy, from June 19-23, 2017, and identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). As a result, the firm's drug product is considered adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. Failure to test drug products for identity and strength of active ingredients prior to release (21 CFR 211.165(a)). 2. Failure to test incoming active pharmaceutical ingredients (API) for identity, purity, or strength, relying instead on unvalidated supplier certificates of analysis (21 CFR 211.84(d)(1) and (2)). 3. Failure to establish written procedures for production and process control, specifically lacking validation of manufacturing processes to ensure batch uniformity and consistent drug quality (21 CFR 211.100(a)). 4. Failure to support drug product expiration dates with appropriate stability testing, admitting no written stability program existed (21 CFR 211.137(a)).

BBCOS srl's July 6, 2017, response committed to no corrective actions, stating an inability to comply