FDA 483 - Patheon Manufacturing Services LLC - July 11, 2018

An FDA inspection of Patheon Manufacturing Services LLC in Greenville, North Carolina, a licensed biological manufacturer, identified two significant observations. The firm failed to adequately investigate and follow up on product technical complaints, specifically regarding leaking vials. Additionally, batch production records were deficient as they did not include required Line Clearance Checklist Forms, raising concerns about quality assurance.