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Fresenius Kabi AG was cited for manufacturing the Ivenix Infusion System (including infusion pump, safety management software, and administration set) in violation of FDA's Current Good Manufacturing Practice requirements under 21 CFR Part 820. The inspection conducted in August-September 2023 at the company's North Andover, Massachusetts facility identified failures to establish adequate corrective and preventive action procedures, as documented in their CAPA procedure (Doc.ID: 410-0013-01). Despite multiple response submissions from company leadership between September and December 2023, the violations remained unresolved.