Patheon Manufacturing Services LLC – FDA EIR, May 24, 2024

An FDA inspection of Patheon Manufacturing Services LLC in Greenville, NC, was conducted from May 15 to May 24, 2024. The inspection focused on the manufacturing of finished sterile human prescription pre-filled syringes, falling under the regulatory framework of Compliance Program 7356.002 and the Food Drug and Cosmetic Act. Investigators identified four significant observations, which were documented on a Form FDA 483. Key issues included the company's failure to adequately validate manufacturing processes to ensure critical defects were controlled. Additionally, Patheon failed to establish and follow proper procedures to prevent microbiological contamination within classified air spaces. The inspection also revealed a failure to implement corrective actions from previous investigations and a lapse in the quality unit's review of original data, such as audit trails and logbooks, prior to batch release. Company management acknowledged these findings and committed to providing a formal response within 15 business days.