# FDA 483 - Patheon Biologics LLC - March 02, 2023

Source: https://www.keypedia.com/records/483/patheon-biologics-llc/0cec7e64-81ac-40a0-bcb4-b82ea16daeba

> FDA 483 for Patheon Biologics LLC on March 02, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2023-03-02
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Patheon Biologics LLC in St. Louis, MO, was inspected and received a Form 483 with four observations. The inspection revealed significant issues with data integrity in laboratory control records, inadequate investigations into deviations and out-of-specification results, scientifically unsound specifications for raw materials, and deficiencies in equipment design and maintenance for contamination control. These findings indicate a need for improved quality system controls and adherence to cGMP requirements.

## Related Documents

- [483 - 2023-11-10](https://www.keypedia.com/records/483/patheon-biologics-llc/3d352468-eb8e-489c-aaf9-7814b0230ae4)
- [483 - 2023-12-08](https://www.keypedia.com/records/483/patheon-biologics-llc/6a07cddb-6465-45e2-9964-326e00b3b830)
- [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

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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