Patheon Biologics LLC – FDA EIR, Mar 2, 2023

An FDA surveillance inspection of Patheon Biologics LLC, a drug substance manufacturer in Saint Louis, MO, was conducted from February 22 to March 2, 2023. This cGMP inspection, focusing on biological drug substances and cell banking operations under Compliance Program 7356.002M, covered Quality, Laboratory, Facility, Equipment, Materials, and Production systems.The inspection revealed four significant findings documented in an FDA Form-483. Primary violations included inadequate protection of laboratory control records, where data from critical analytical instruments lacked safeguards against manipulation or deletion. There was also an absence of procedures for appropriately managing manual data integration within chromatography systems, with numerous instances observed lacking proper explanation.Further issues comprised insufficient investigation records for critical deviations and out-of-specification results, specifically noting inadequate root cause determinations. The firm also failed to ensure the quality of critical incoming raw materials through comprehensive testing. Lastly, equipment maintenance was deficient, highlighted by a lack of routine calibration and adherence to qualified operating ranges for a Controlled Rate Freezer.Patheon Biologics LLC's management stated they would submit a written response to the FDA's observations within 15 business days.