FDA 483 - BEO Pharma Inc - November 04, 2024

An FDA inspection of BEO Pharma Inc. dba BEO Pharmaceuticals Inc. in Brooksville, FL, revealed significant deficiencies across its quality control, laboratory, production, and materials systems. The firm failed to adequately follow quality unit procedures, ensure proper testing and release of drug products, establish sound laboratory controls, conduct process validations, and verify the identity of incoming raw materials. These issues indicate a lack of robust controls for manufacturing OTC drug products.