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

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.