FDA 483 - Fresenius Kabi USA LLC - June 30, 2022

Fresenius Kabi USA, LLC, a drug product manufacturer in Melrose Park, IL, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in quality control, including inadequate investigations into product discrepancies and particulate matter, failures in aseptic processing procedures, and incomplete laboratory and batch records. Additionally, the firm lacked proper training for employees on revised manufacturing processes and did not follow written procedures for packaging and labeling materials.