# FDA 483 - Patheon Biologics LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/patheon-biologics-llc/7c77e3e0-9e80-4d41-b1df-38b17ba0018e

> FDA 483 for Patheon Biologics LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Product Type: biologics
- Office Name: Division of Inspectional Assessment
- Summary: The FDA inspection of Patheon Biologics LLC in St. Louis, MO, identified significant deficiencies in their drug substance manufacturing operations. Issues included inadequate controls to prevent microbial contamination, insufficient monitoring of critical process parameters, and poorly defined or followed written procedures. These findings led to bioreactor contaminations, environmental control failures, and delayed responses to deviations, indicating a need for robust quality system improvements.

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## Related Officers

- [Masood Rahimi, Ph.D., Chemist](https://www.globalkeysolutions.net/people/masood-rahimi-phd-chemist/22ea52d9-cd9a-4e8f-87c2-bfb67a39664c)
- [Joslyn Brunelle, Ph.D., Lead Biologist](https://www.globalkeysolutions.net/people/joslyn-brunelle-phd-lead-biologist/8f4024b1-6495-4e1d-90a4-a0332f0cbed6)
- [Bo Chi, Ph.D., Microbiologist](https://www.globalkeysolutions.net/people/bo-chi-phd-microbiologist/69ddbe08-9e55-44fa-8cc3-96b19c9b21fd)

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

Office: https://www.globalkeysolutions.net/offices/division-of-inspectional-assessment/9bc7aff2-93a7-404a-8015-0f93c3701c13