# FDA 483 - Patheon Biologics LLC - November 10, 2023

Source: https://www.keypedia.com/records/483/patheon-biologics-llc/3d352468-eb8e-489c-aaf9-7814b0230ae4

> FDA 483 for Patheon Biologics LLC on November 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2023-11-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Patheon Biologics LLC, Pharma Services-Thermo Fisher Scientific in Saint Louis, MO, revealed significant deficiencies in their drug substance manufacturing operations. Observations included inadequate and unfollowed standard operating procedures, ineffective corrective and preventive action (CAPA) oversight for recurring issues, and improper labeling of cGMP materials. Additionally, issues with equipment maintenance, stability testing studies, and quality oversight of training were noted, indicating systemic control weaknesses.

## Related Documents

- [483 - 2023-12-08](https://www.keypedia.com/records/483/patheon-biologics-llc/6a07cddb-6465-45e2-9964-326e00b3b830)
- [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

- [Xiaoshi Wang](https://www.keypedia.com/people/xiaoshi-wang/8249ff14-dec6-4ffd-9893-bdf8ba6af7ce)
- [Harnet M. Toure](https://www.keypedia.com/people/harnet-m-toure/bb072cd0-7006-4054-8d1a-d26cccb97862)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [company_representative](https://www.keypedia.com/people/li-yongmin/eb42eb61-6778-472f-b850-d043c2fe7d49)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd