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

Source: https://www.keypedia.com/records/483/owen-biosciences-inc/c194332c-b426-4464-b761-f4e8e68c4af4

> FDA 483 for Owen Biosciences Inc. on May 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Owen Biosciences Inc.
- Inspection Date: 2026-05-15
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: 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.

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## Related Officers

- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/owen-biosciences-inc/a884ad6d-40ba-4df7-8385-49f52b3dff62

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea