FDA 483 - Cosmetic Specialty Labs, Inc - September 20, 2023

Cosmetic Specialty Labs, Inc., a contract drug manufacturer in Lawton, OK, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to adhere to quality control unit responsibilities, lacked process validation and stability testing programs, and exhibited inadequate laboratory controls and equipment cleaning procedures. These issues indicate a systemic failure to ensure the quality, purity, and safety of their OTC drug products.