Bicooya Cosmetics Limited – FDA Warning Letter, May 25, 2017

On August 11, 2017, the FDA issued a Warning Letter to Bicooya Cosmetics Limited following an inspection from May 22-25, 2017, which revealed significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). The FDA determined the company's drug products are adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations included: 1. **Pest Infestation:** Rodent feces were observed throughout the facility, near filling machines, the water system, and in the warehouse around raw materials and finished drug products, including OTC ointments. (21 CFR 211.56(a)) 2. **Equipment Maintenance:** Residue build-up in manufacturing tanks and damaged transfer hoses held together with plastic wrap were observed. A tank hinge broke during inspection. (21 CFR 211.67(a)) 3. **Inadequate Product Testing:** The firm failed to test all lots of drug products for active ingredient content and did not conduct microbial testing for each batch prior to release, citing customer requirements for less frequent testing. (21 CFR 211.165(a)) 4. **Incomplete Batch Records and Data Integrity Issues:** The firm could not provide complete batch records for distributed OTC