# FDA 483 - Patheon Biologics LLC - December 08, 2023

Source: https://www.keypedia.com/records/483/patheon-biologics-llc/6a07cddb-6465-45e2-9964-326e00b3b830

> FDA 483 for Patheon Biologics LLC on December 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2023-12-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Patheon Biologics, LLC in St. Louis, MO, revealed significant deficiencies in deviation investigations, environmental controls, and facility maintenance. The firm failed to thoroughly investigate leaks in production suites for potential microbial growth and lacked adequate documentation and tracking for environmental monitoring. Additionally, the facility exhibited poor maintenance with cracks in ceilings and visible residue buildup in production areas and hallways.

## Related Documents

- [483 - 2023-11-10](https://www.keypedia.com/records/483/patheon-biologics-llc/3d352468-eb8e-489c-aaf9-7814b0230ae4)
- [483 - 2023-03-02](https://www.keypedia.com/records/483/patheon-biologics-llc/0cec7e64-81ac-40a0-bcb4-b82ea16daeba)
- [EIR - 2023-03-02](https://www.keypedia.com/records/eir/patheon-biologics-llc/be1b1e64-d9a3-4c83-b83c-13437f976c68)
- [EIR - 2019-08-02](https://www.keypedia.com/records/eir/patheon-biologics-llc/35caa8c6-9f70-4411-9b43-028267777ca4)
- [EIR - 2023-11-10](https://www.keypedia.com/records/eir/patheon-biologics-llc/17b3c6b9-a62c-4cf6-8567-bbafecbcb8e8)

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8