Patheon Manufacturing Services LLCAugust 14, 2020

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

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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.

Company: Patheon Manufacturing Services LLC
Inspection Date: August 14, 2020
Product Type: Drugs
Office: Division of Blood Components and Devices
People: Yun Wu, Ph.D.
Viviana Matta (FDA Biologics Investigator)

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ID · 8d7873d2-fefa-4886-889a-513ce99dd08b