FDA 483 - Owen Biosciences Inc. - March 27, 2025

Owen Biosciences Inc. in Baton Rouge, LA, an OTC drug manufacturer, was cited for multiple significant deficiencies related to its quality control unit, laboratory controls, and stability programs during an FDA inspection. The firm failed to establish adequate specifications and impurity testing for its Skin PS 2.5% BP Lotion, lacked sufficient stability data to support product expiration dates, and had an ineffective quality unit with absent or incomplete procedures for critical GMP processes. These issues indicate a systemic breakdown in ensuring the quality, purity, and strength of its drug products.