FDA 483 - Polpharma Biologics S.A - March 22, 2022

During an inspection conducted by the U.S. FDA from March 14-18 and March 21-22, 2022, Polpharma Biologics S.A. in Gdańsk, Poland, received an FDA Form 483 detailing significant observations regarding its manufacturing practices. The inspection revealed multiple deviations from Good Manufacturing Practices (GMP) across various operational areas. Key issues included inadequacies in establishing and validating manufacturing process controls, such as incomplete operating ranges for critical parameters and a lack of disinfectant efficacy studies. Sampling procedures were found to be deficient, with improper point-of-use sampling and incorrect storage of stability samples. The facility's cleaning and disinfection protocols were also cited for not ensuring appropriate contact times. Furthermore, changes to manufacturing processes were not adequately evaluated or re-qualified, and several Standard Operating Procedures were either inadequate or not consistently followed, impacting sample collection and analytical methods. Other observations included facility design not conducive to proper cleaning, insufficient testing of incoming components like packaging materials, and a lack of established systems for sanitization and comprehensive investigation of discrepancies. The firm also lacked proper testing for container closure integrity and written labeling procedures for drug substances. To address these findings, Polpharma Biologics S.A. must implement comprehensive corrective and preventive actions to ensure full compliance with FDA's GMP regulations for drug substance manufacturing.