# Patheon Manufacturing Services LLC – FDA 483, Aug 7, 2026

Source: https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/a3df7a01-ba29-4f0f-8b19-f2f5def27dc1

> FDA 483 for Patheon Manufacturing Services LLC on August 07, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2026-08-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Patheon Manufacturing Services LLC in Greenville, NC, revealed critical deficiencies in its sterile drug product manufacturing operations. The firm exhibited inadequate quality unit control over GMP documents, failed to establish robust production and process controls, and demonstrated significant lapses in aseptic processing, environmental monitoring, and visual inspection programs. These issues collectively indicate a high risk to the quality and sterility assurance of manufactured drug products.

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## Related Officers

- [Liqun Zhao, Ph.D., Pharmaceutical Scientist](https://www.keypedia.com/people/liqun-zhao-phd-pharmaceutical-scientist/119c5df8-ab47-4059-9c89-db6490dff7df)
- [Wei-chen (Ben) Du, Ph.D., Pharmaceutical Scientist](https://www.keypedia.com/people/wei-chen-ben-du-phd-pharmaceutical-scientist/a1d42882-1d0e-430f-9976-d672dcfd946b)
- [Jianli Xue, Ph.D., Senior Microbiologist](https://www.keypedia.com/people/jianli-xue-phd-senior-microbiologist/b2ed6b1a-6ea7-4245-945a-fecdee2c16d1)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4