# FDA 483 - Thorn BioScience LLC - May 26, 2023

Source: https://www.keypedia.com/records/483/thorn-bioscience-llc/cd3ae3c9-27ad-43ff-877f-508e436ced9d

> FDA 483 for Thorn BioScience LLC on May 26, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thorn BioScience LLC
- Inspection Date: 2023-05-26
- Product Type: veterinary
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Thorn BioScience LLC in Louisville, KY, a manufacturer, revealed significant deficiencies in laboratory control mechanisms and quality review processes. The firm's analysts could delete raw data without adequate controls or audit trails, indicating a severe data integrity issue. Additionally, the company failed to perform an annual product quality review for Sucramate and lacked proper procedures for inspecting retain samples.

## Related Documents

- [483 - 2019-06-07](https://www.keypedia.com/records/483/thorn-bioscience-llc/8a360ecb-3d78-4939-bdd4-9524b1a93518)
- [483 - 2024-05-22](https://www.keypedia.com/records/483/thorn-bioscience-llc/471965d8-cebf-4b34-a583-5b93c3008a6a)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/thorn-bioscience-llc/5ddc639e-2869-44b2-bbd3-e2263558b394

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22