# FDA 483 - Patheon Manufacturing Services LLC - August 14, 2020

Source: https://www.globalkeysolutions.net/records/483/patheon-manufacturing-services-llc/4a32f26e-a7ed-4224-8fcc-32ec2b104484

> FDA 483 for Patheon Manufacturing Services LLC on August 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2020-08-14
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Patheon Manufacturing Services, LLC. in Greenville, NC, a drug product manufacturer, revealed significant deficiencies in their quality control unit's adherence to written procedures. Issues included inadequate change management, supplier qualification, sample handling, and deviation investigations. Furthermore, the facility's system for cleaning and disinfecting aseptic areas was found to be inadequate, with disinfectants ineffective against prevalent house isolates.

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## Related Officers

- [Viviana Matta, Consumer Safety Officer](https://www.globalkeysolutions.net/people/viviana-matta-consumer-safety-officer/d01f627b-6a12-42b2-9ef8-7500f5f7f98b)
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Company: https://www.globalkeysolutions.net/companies/patheon-manufacturing-services-llc/64087a9c-0f9c-44d7-aeb9-171f7bc13658

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321