Fresenius Kabi USA LLC – FDA 483, Aug 24, 2023

Fresenius Kabi USA LLC in Melrose Park, IL, a sterile drug manufacturer, received a Form 483 citing significant deficiencies in their quality control unit's procedures. Observations included improper bioburden plate enumeration for Water for Injection samples, incorrect personnel monitoring practices in the aseptic core, and a failure to contemporaneously record data in QC chemistry logbooks. These issues indicate a lack of adherence to established procedures and data integrity principles.