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

The Food and Drug Administration (FDA) issued a Warning Letter to Owen Biosciences, Inc. following an inspection of their Baton Rouge facility from March 25 to 27, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. Key violations include the firm"s failure to establish adequate laboratory controls, particularly for their topical over-the-counter drug products containing benzoyl peroxide. The FDA found that the company did not conduct benzene testing prior to release, despite a known degradation pathway to this carcinogen, and an FDA analysis revealed excessive benzene levels (over 20 ppm) in one product lot. Furthermore, the company"s stability program was found to be inadequate, failing to ensure product quality throughout its shelf life with proper testing for identity, microbiology, and impurities. Lastly, the quality control unit failed to provide sufficient oversight, evidenced by deficiencies in reviewing records, investigating issues, and performing periodic product reviews. The FDA requires Owen Biosciences to provide a detailed plan for benzene testing, a comprehensive assessment and action plan for all distributed drug products within expiry, and an independent review and remediation of their laboratory practices and stability program. This includes validated testing methods and a commitment to ongoing stability studies to ensure product safety and quality.