Fresenius Kabi USA, LLC – FDA EIR, Feb 4, 2016

An FDA inspection of Fresenius Kabi USA, LLC’s Grand Island, NY facility was conducted from January 27 to February 4, 2016, to assess compliance with current Good Manufacturing Practices (cGMP) for sterile human drug products under 21 CFR Part 211. The inspection identified a five-item FDA Form 483, detailing several significant violations across its quality, production, facilities and equipment, and laboratory control systems. Key issues included failures to adequately review and account for controlled laboratory test records prior to batch release, and to thoroughly investigate unexplained discrepancies stemming from facilities/equipment damage and market complaints. The firm also repeatedly failed to implement effective measures to prevent damage to glass vials during media fills, which led to contamination. Additionally, operator training on revised procedures was found to be deficient, and the justification for minimum sampling plans for microbiological testing of sterile drug products after microbial excursions was deemed inadequate. Fresenius Kabi management committed to evaluating and implementing voluntary Corrective and Preventive Actions. The FDA warned that failure to address these observations could result in further regulatory actions, with the final inspection classification pending review of the comprehensive report and the company’s formal response.