# FDA 483 - Patheon Biologics LLC - May 02, 2022

Source: https://www.keypedia.com/records/483/patheon-biologics-llc/d6ce1e74-8ba4-44b4-8402-de3cf9149ba6

> FDA 483 for Patheon Biologics LLC on May 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2022-05-02
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Patheon Biologics LLC in St. Louis, MO, a drug substance manufacturer, identified three significant observations. These included deficiencies in the qualification, monitoring, and alarming of temperature-controlled storage areas for cGMP materials. Additionally, the firm was cited for inadequate labeling of cGMP materials and discrepancies between batch records/SOPs and actual manufacturing/laboratory procedures.

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## Related Officers

- [Brian Roelofs](https://www.keypedia.com/people/brian-roelofs/1c88e738-0ca2-41bd-917e-1d02fdd05cf2)
- [Ian L. McWilliams](https://www.keypedia.com/people/ian-l-mcwilliams/386bf0ca-a66d-4526-9b07-7771795269a1)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0