# FDA 483 - Thorn BioScience LLC - May 22, 2024

Source: https://www.keypedia.com/records/483/thorn-bioscience-llc/471965d8-cebf-4b34-a583-5b93c3008a6a

> FDA 483 for Thorn BioScience LLC on May 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thorn BioScience LLC
- Inspection Date: 2024-05-22
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Thorn BioScience LLC in Louisville, KY, was inspected by the FDA from May 14-22, 2024, and received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results and discrepancies, insufficient equipment cleaning records, and improper reserve sample quantities. Additionally, issues were noted in computer system controls, procedures for preventing microbiological contamination of sterile products, and aseptic processing area disinfection protocols.

## Related Documents

- [483 - 2019-06-07](https://www.keypedia.com/records/483/thorn-bioscience-llc/8a360ecb-3d78-4939-bdd4-9524b1a93518)
- [483 - 2023-05-26](https://www.keypedia.com/records/483/thorn-bioscience-llc/cd3ae3c9-27ad-43ff-877f-508e436ced9d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

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