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Talk to a SpecialistTalk to a SpecialistOwen Biosciences, Inc. manufactured over-the-counter topical drug products containing benzoyl peroxide without establishing adequate laboratory controls or specifications to ensure product safety and quality. The company failed to conduct benzene testing on finished products prior to release, despite benzoyl peroxide's known degradation mechanism that can produce benzene, a known carcinogen, under certain conditions. The FDA inspection on March 25-27, 2025 found that the firm's manufacturing methods, facilities, and controls did not conform to Current Good Manufacturing Practice regulations, rendering their drug products adulterated and in violation of the Federal Food, Drug, and Cosmetic Act.