Owen Biosciences Inc.May 15, 2026

FDA 483 - Owen Biosciences Inc. - May 15, 2026

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Record Details

Owen Biosciences Inc. in Baton Rouge, LA, a contract manufacturer of non-sterile OTC drug products, was cited for significant quality control deficiencies during an FDA inspection. The inspection revealed failures in preventing objectionable microorganisms, investigating out-of-specification results, and ensuring the overall adequacy of its quality system. These issues indicate a broad lack of adherence to good manufacturing practices.

Company: Owen Biosciences Inc.
Inspection Date: May 15, 2026
Product Type: Drugs
Office: New Orleans District Office
Person: Brittny C. Cargo (Medical Officer at FDA)

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