# FDA 483 - Patheon Biologics LLC - January 24, 2023

Source: https://www.globalkeysolutions.net/records/483/patheon-biologics-llc/873b0edd-030b-43fa-98b0-e9085b4a11de

> FDA 483 for Patheon Biologics LLC on January 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2023-01-24
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Patheon Biologics LLC, a drug substance manufacturer in Saint Louis, MO, revealed significant deficiencies across multiple areas. Observations included inadequate facility cleaning and maintenance leading to mold contamination, insufficient control of manufacturing processes, and incomplete risk assessments for viral contamination. Additionally, issues were noted with the segregation and management of expired raw materials, inadequate maintenance programs, and improper labeling of GMP materials and equipment.

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## Related Officers

- [Dilip D. Devineni](https://www.globalkeysolutions.net/people/dilip-d-devineni/e03f6256-3a25-43ca-80f5-0f193dcc1fd8)
- [Zhang Zhao](https://www.globalkeysolutions.net/people/zhang-zhao/30c01178-37ff-446c-8ade-e3515627e723)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

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

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