Fresenius Kabi AG

Warning LetterOpen

Pierluigi Antonelli CEO Fresenius Kabi AG Else-Kroner-Str. 1 61352 Bad Homburg GermanyFEI 3014215309Issued Jan 4, 2024Center for Devices and Radiological Health

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Violations12

Issue DateJan 4, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Fresenius Kabi AG
Location: Pierluigi Antonelli CEO Fresenius Kabi AG Else-Kroner-Str. 1 61352 Bad Homburg Germany
FEI Number: 3014215309
Country: Germany
Issue Date: January 04, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Fresenius Kabi AG FDA Warning Letter, January 4, 2024