FDA EIR - Patheon Pharmaceuticals Inc. - February 14, 2018

An FDA routine surveillance inspection of Patheon Pharmaceuticals Inc., operating as Thermo Fisher Scientific, was conducted from February 5 to February 14, 2018. The inspection, carried out under standard drug manufacturing guidelines (CPGM 7356.002) and subject to FD&C Act regulations, identified six significant observations requiring corrective action. Key issues noted in the FDA-483 report included inadequate equipment maintenance, specifically visible rust on manufacturing equipment, tools, and packaging machinery, as well as a chipped hose in a coating pan, raising potential contamination concerns. The facility also failed to maintain adequate control over its environment, with apparent insect presence in production areas and water dripping onto raw materials in the warehouse, indicating building disrepair. Furthermore, the inspection revealed deficiencies in the company's quality management systems. Equipment calibration was found to be overdue, and investigations into manufacturing deviations, corrective and preventive actions (CAPAs), and out-of-specification results were not consistently conducted according to the firm’s established procedures, with many exceeding target completion dates or lacking proper interim reporting. Additionally, an investigation into a potential product mix-up was not appropriately expanded to all potentially affected batches. Patheon Pharmaceuticals Inc. management acknowledged the findings and committed to providing a formal response addressing these observations within 15 business days, outlining their planned corrections to ensure compliance with pharmaceutical manufacturing standards.