# Patheon Biologics LLC – FDA 483, Jul 30, 2019

Source: https://www.keypedia.com/records/483/patheon-biologics-llc/f6a7efc4-6745-4388-be00-216d9701cbf2

> FDA 483 for Patheon Biologics LLC on July 30, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics LLC
- Inspection Date: 2019-07-30
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Thermo Fisher Scientific dba Patheon Biologics LLC in St. Louis, MO, an API (Biotech) Manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination in sterile processing, poor facility maintenance with chipped paint, and failures in validating supplier Certificates of Analysis. Additionally, the firm lacked proper equipment calibration and maintenance programs, failed to maintain equipment use logs, and did not consistently follow or contemporaneously document production and process control procedures.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

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