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

Source: https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/8d7873d2-fefa-4886-889a-513ce99dd08b

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

---

## Details

- Record Type: 483
- Company Name: Patheon Manufacturing Services LLC
- Inspection Date: 2020-08-14
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: Patheon Manufacturing Services, LLC in Greenville, NC, was inspected and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's quality control unit, including issues with change management, supplier qualification, sample handling, and deviation investigations. Additionally, the facility's cleaning and disinfection program for aseptic areas was found to be inadequate, with disinfectants proving ineffective against prevalent environmental isolates.

## Related Documents

- [483 - 2014-09-12](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/79b91b77-43a2-4173-98dc-9cfaa27a6e92)
- [WARNING_LETTER - 2022-01-25](https://www.keypedia.com/records/warning_letter/patheon-manufacturing-services-llc/a31b625f-da20-431d-bdca-d1753a931b89)
- [483 - 2015-12-17](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/eca9e1b0-47c9-44ab-8a3a-54aa3f4fb96b)
- [483 - 2022-08-04](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/8e4e84cb-149a-4f4e-ab0a-5b04481cdbc7)
- [483 - 2020-08-14](https://www.keypedia.com/records/483/patheon-manufacturing-services-llc/4a32f26e-a7ed-4224-8fcc-32ec2b104484)

## Related Officers

- [Yun Wu, Ph.D.](https://www.keypedia.com/people/yun-wu-phd/dbe8aaf9-1f1b-4ecb-a5c9-d65d1a816a96)
- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)

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

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917