# FDA 483 - Patheon Manufacturing Services LLC - November 14, 2016

Source: https://www.globalkeysolutions.net/records/483/patheon-manufacturing-services-llc/8b6329a2-0c1e-421b-a5dd-ac3f754a6f06

> FDA 483 for Patheon Manufacturing Services LLC on November 14, 2016. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2016-11-14
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Patheon Manufacturing Services, LLC in Greenville, NC, a contract manufacturing organization, was cited for significant deficiencies during an FDA inspection. Observations included a lack of validated cleaning procedures, inadequate written procedures for packaging and labeling, and insufficient controls for testing and approving drug product containers and closures. Additionally, the firm lacked adequate written procedures for its visual inspection program for vaccine products.

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## Related Officers

- [Michele L. Forster, PhD, Investigator](https://www.globalkeysolutions.net/people/michele-l-forster-phd-investigator/aa148983-2b26-4359-9097-ab0d7066ab93)
- [investigator](https://www.globalkeysolutions.net/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd