# FDA 483 - Patheon Manufacturing Services LLC - May 24, 2024

Source: https://www.globalkeysolutions.net/records/483/patheon-manufacturing-services-llc/f9088480-8d21-4417-b522-e1da3a9a0bd7

> FDA 483 for Patheon Manufacturing Services LLC on May 24, 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: 2024-05-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Patheon Manufacturing Services LLC in Greenville, NC, was cited for significant deficiencies in its sterile drug manufacturing operations. The inspection revealed inadequate production and process controls, including issues with visual inspection, process validation, and environmental monitoring for microbiological contamination. Additionally, the firm's quality control unit failed to adequately investigate deviations and ensure data integrity.

## Related Documents

- [WARNING_LETTER - 2022-01-25](https://www.globalkeysolutions.net/records/warning_letter/patheon-manufacturing-services-llc/a31b625f-da20-431d-bdca-d1753a931b89)
- [483 - 2025-09-26](https://www.globalkeysolutions.net/records/483/patheon-manufacturing-services-llc/6cc28f8d-7cd6-4df2-93e5-5f149479d4af)
- [483 - 2014-09-12](https://www.globalkeysolutions.net/records/483/patheon-manufacturing-services-llc/79b91b77-43a2-4173-98dc-9cfaa27a6e92)
- [EIR - 2022-08-04](https://www.globalkeysolutions.net/records/eir/patheon-manufacturing-services-llc/856a179c-34ae-4091-9c26-cda953efa768)
- [EIR - 2021-11-12](https://www.globalkeysolutions.net/records/eir/patheon-manufacturing-services-llc/209f9ad1-731b-4042-9bd9-aaa9825b74cc)

## Related Officers

- [Zhong Li](https://www.globalkeysolutions.net/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Saundra A. Munroe](https://www.globalkeysolutions.net/people/saundra-a-munroe/8e9b8973-5ac4-4a2a-ab26-1618c0e434e7)
- [Melanie Walker](https://www.globalkeysolutions.net/people/melanie-walker/fd9d56d8-ff97-4d11-94de-89711d91e51e)

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

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