FDA 483 - Fresenius Kabi USA LLC - December 11, 2013

An FDA inspection of Fresenius Kabi USA LLC in Melrose Park, IL, a sterile injectable drug product manufacturer, revealed significant deficiencies. These included failures in following quality control unit procedures, inadequate equipment design for cleaning, and a lack of established procedures to prevent microbiological contamination. These issues led to product recalls and potential risks to product sterility.