FDA 483 - Clean Solutions LLC - September 27, 2023

During an inspection conducted from August 21 to September 27, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Fresenius Kabi USA, LLC, a drug manufacturer located in Melrose Park, IL. The inspection revealed significant observations concerning the firm's adherence to current Good Manufacturing Practices (cGMP) for sterile drug products. Key issues included a lack of adequate validation for sterilization processes, specifically concerning environmental monitoring (EM) sampling locations in Grade A/B manufacturing areas, which was noted as a repeat observation. The firm also failed to perform a documented risk assessment for EM sampling in the Grade C common corridor. Furthermore, personnel were observed with exposed skin in aseptic filling rooms, and materials were not properly disinfected before entering critical aseptic processing areas. Additional observations highlighted deficiencies in microbial identification procedures, as only mold, not bacteria, was identified from EM and personnel monitoring samples exceeding action levels. The quality control unit lacked full authority, as stoppers were accepted without identity testing. Lastly, non-viable particle counters and isokinetic sampling probes, critical for monitoring aseptic areas, were not calibrated under conditions of use, and their tubing was not evaluated for particle loss. Fresenius Kabi USA, LLC is required to address these serious observations to ensure the sterility and quality of its drug products.