# FDA 483 - Thorn BioScience LLC - June 07, 2019

Source: https://www.globalkeysolutions.net/records/483/thorn-bioscience-llc/8a360ecb-3d78-4939-bdd4-9524b1a93518

> FDA 483 for Thorn BioScience LLC on June 07, 2019. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thorn BioScience LLC
- Inspection Date: 2019-06-07
- Product Type: veterinary
- Office Name: Cincinnati District Office
- Summary: Thorn BioScience LLC in Louisville, KY, was inspected from June 3-7, 2019, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in computer system controls, including lack of system administrator accountability and audit trail review. Additionally, the firm lacked appropriate statistical quality control criteria for visual inspection, had incomplete laboratory records regarding analyst and reviewer signatures, and had deficient cleaning and maintenance procedures.

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

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