# FDA 483 - Patheon Biologics LLC - November 20, 2024

Source: https://www.globalkeysolutions.net/records/483/patheon-biologics-llc/d1ed2422-f64d-4561-9a76-42c52c171eb9

> FDA 483 for Patheon Biologics LLC on November 20, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2024-11-20
- Product Type: biologics
- Office Name: Kansas City District Office
- Summary: Patheon Biologics LLC in Saint Louis, MO, was inspected by the FDA, revealing significant issues in quality control and laboratory procedures. The inspection found failures in thoroughly investigating unexplained discrepancies and customer complaints, including issues with particulate matter and packaging integrity. Additionally, laboratory testing procedures for materials were not fully documented, specifically regarding bacterial endotoxin testing.

## Related Documents

- [483 - 2023-11-10](https://www.globalkeysolutions.net/records/483/patheon-biologics-llc/3d352468-eb8e-489c-aaf9-7814b0230ae4)
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- [EIR - 2023-03-02](https://www.globalkeysolutions.net/records/eir/patheon-biologics-llc/be1b1e64-d9a3-4c83-b83c-13437f976c68)
- [EIR - 2019-08-02](https://www.globalkeysolutions.net/records/eir/patheon-biologics-llc/35caa8c6-9f70-4411-9b43-028267777ca4)

## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)
- [Ogechi C. Nna](https://www.globalkeysolutions.net/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)
- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)
- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.globalkeysolutions.net/companies/patheon-biologics-llc/f1012be8-80da-4749-b923-0c97e2b6d47f

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79