FDA 483 - Patheon Manufacturing Services LLC - August 04, 2022

An FDA inspection of Patheon Manufacturing Services LLC in Greenville, NC, revealed critical deficiencies in aseptic processing, facility design, and quality system investigations. The firm failed to adhere to procedures designed to prevent microbial contamination, operated in a facility with unsuitable space hindering aseptic technique, and conducted inadequate investigations into unexplained discrepancies and foreign particle complaints. These observations indicate significant risks to the quality and sterility of drug products manufactured at the facility.