# FDA 483 - Patheon Manufacturing Services LLC - December 17, 2015

Source: https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/eca9e1b0-47c9-44ab-8a3a-54aa3f4fb96b

> FDA 483 for Patheon Manufacturing Services LLC on December 17, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2015-12-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Patheon Manufacturing Services, LLC in Greenville, NC, identified three significant deficiencies. The firm failed to properly determine and investigate packaging yields for drug products, lacked appropriate storage conditions for drug products, and did not adequately document laboratory control mechanisms. These observations indicate a need for improved adherence to good manufacturing practices.

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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