FDA 483 - Fresenius Kabi USA, LLC - October 13, 2023

An FDA inspection of Fresenius Kabi USA, LLC in Grand Island, NY, identified critical deficiencies in aseptic processing and quality control for sterile drug products. The firm failed to establish and follow adequate procedures to prevent microbiological contamination, including issues with environmental monitoring, airflow studies, and documentation of aseptic interventions. Additionally, the company did not thoroughly investigate unexplained discrepancies, such as recurring grease contamination during the production of Heparin Sodium Injection, USP, which was subsequently distributed.