FDA 483 - Fresenius Kabi USA LLC - May 18, 2020

An FDA inspection of Fresenius Kabi USA LLC in Melrose Park, IL, revealed significant deficiencies in quality control, equipment cleaning, aseptic processing, batch record documentation, and investigation procedures. The firm failed to adequately address particulate matter in Ketorolac, cross-contamination with Lidocaine in Dexmedetomidine, and lacked proper controls for sterile drug product manufacturing and hold times. These issues indicate a lack of adherence to current good manufacturing practices.