# FDA 483 - Patheon Manufacturing Services LLC - July 11, 2018

Source: https://www.globalkeysolutions.net/records/483/patheon-manufacturing-services-llc/e49dd59c-e401-42aa-b19c-22a2ad1c274c

> FDA 483 for Patheon Manufacturing Services LLC on July 11, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2018-07-11
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Patheon Manufacturing Services LLC in Greenville, North Carolina, a licensed biological manufacturer, identified two significant observations. The firm failed to adequately investigate and follow up on product technical complaints, specifically regarding leaking vials. Additionally, batch production records were deficient as they did not include required Line Clearance Checklist Forms, raising concerns about quality assurance.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

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