FDA 483 - Patheon Pharmaceuticals Inc. - February 14, 2018

An FDA inspection conducted at Patheon Pharmaceuticals Inc. from February 5-14, 2018, resulted in a Form FDA 483, documenting significant observations regarding the firm’s compliance with good manufacturing practices. Investigators identified multiple issues across various areas of operation. Key violations included inadequate equipment maintenance, specifically the presence of rust on critical drug production equipment like sifters, drum loaders, and tools, as well as chipped paint and worn metal on cottoners, risking product contamination. A damaged hose inside a coating pan and fraying duct tape on portable equipment also raised concerns. Facility maintenance issues were noted, with observations of dead insects, damaged walls, and rust on supply vents in packaging and processing areas, along with water dripping onto raw materials in the warehouse. Furthermore, the inspection revealed deficiencies in quality control and procedural adherence. An encapsulator used for drug manufacturing was found to be operating past its calibration due date. The company also failed to follow its own written procedures for investigations, with a high percentage of deviations exceeding completion timelines without interim reports, incomplete Corrective and Preventive Actions (CAPAs), and stability out-of-specification investigations not being finalized promptly. Additionally, an investigation into a copper wire found in a mill after manufacturing was not expanded to include prior batches, indicating a lack of thoroughness. These observations signify a failure to ensure the safety, identity, strength, quality, and purity of drug products, falling under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Patheon Pharmaceuticals is expected to implement comprehensive corrective actions to address these serious deficiencies and achieve full compliance with cGMP regulations.