# FDA 483 - Patheon Manufacturing Services LLC - February 23, 2024

Source: https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/9361c433-63b1-4a97-b5fe-1d18c38a1ade

> FDA 483 for Patheon Manufacturing Services LLC on February 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2024-02-23
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Patheon Manufacturing Services LLC, a contract drug manufacturer in Greenville, NC, identified one observation related to laboratory control mechanisms. The firm failed to properly label settle plates used for environmental monitoring during final drug product sterility release testing, specifically lacking expiration dates. This indicates a deficiency in following established laboratory control procedures.

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## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/patheon-manufacturing-services-llc/64087a9c-0f9c-44d7-aeb9-171f7bc13658

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7