FDA 483 - Belcher Pharmaceuticals, LLC - November 15, 2021

An FDA inspection of Belcher Pharmaceuticals, LLC in Largo, FL, revealed significant deficiencies in laboratory controls, production and process controls, batch recordkeeping, quality unit responsibilities, and facility maintenance. The firm failed to verify testing methods, lacked written procedures for critical processes, had incomplete batch records, and did not ensure proper quality unit oversight. Additionally, basic facility requirements like hot water in restrooms were not met, indicating a broad range of issues impacting drug product quality and safety.