FDA 483 - Fresenius Kabi Austria GMBH - March 28, 2023

An FDA inspection of Fresenius Kabi Austria GmbH - (FK-Graz) in Graz, Austria, a drug product manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish or follow adequate process controls, leading to potential contamination risks, issues with aseptic processing, and uncalibrated equipment. Additionally, a utility system was found to be improperly located and maintained, and several manufacturing and validation procedures were deemed deficient.