FDA 483 - Fresenius Kabi Austria Gmbh - March 20, 2017

Fresenius Kabi Austria Gmbh in Linz, Austria, an API and drug product manufacturer, was cited for significant deficiencies across its quality control, facility maintenance, and reprocessing procedures. The inspection revealed widespread issues with data integrity, including unjustified repetitive testing, lack of investigation into anomalies, and absence of audit trails on critical analytical instruments. Additionally, the firm failed to maintain facilities and equipment adequately, and reprocessed drug products without proper stability assessments.