FDA EIR - Patheon Manufacturing Services LLC - March 28, 2018

Patheon Manufacturing Services, LLC, located in Greenville, NC, underwent an FDA inspection from March 26-28, 2018. This abbreviated Level 1 Quality System inspection focused on the company's sterile pharmaceutical manufacturing operations, specifically evaluating the processing of an API-filled syringe, considered a drug/device combination product under NDA 210655. The inspection, requested by the Center for Devices and Radiological Health (CDRH), was conducted using the Quality System Inspection Technique (QSIT) Guide and Compliance Program 7382.845 for medical device manufacturers. The inspection covered various systems including Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control. While no formal FDA Form 483 (Inspectional Observations) was issued, the FDA investigator discussed two verbal observations with company management: inappropriate control of labeling material and inappropriate control of active pharmaceutical ingredient (API) material. The review of activities related to the device portion of NDA 210655 revealed no apparent deficiencies. Although no specific corrective actions were formally mandated through a 483, the firm was reminded of its ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic Act and associated federal regulations.