FDA 483 - Patheon Manufacturing Services LLC - September 12, 2014

Patheon Manufacturing Services, LLC, a sterile drug manufacturer in Greenville, NC, was inspected by the FDA from September 9-12, 2014, and received four observations. The inspection revealed deficiencies in aseptic processing area cleaning, equipment sanitization, environmental monitoring, and sterility testing procedures. These issues indicate a moderate level of concern regarding the firm's control over its sterile manufacturing processes.