Fresenius Kabi AG – FDA Warning Letter, Sep 7, 2023

On January 4, 2024, the FDA issued a Warning Letter to Fresenius Kabi USA, LLC, following an inspection from August 15 to September 7, 2023. The inspection revealed that the Ivenix Infusion System (including pump, software, and administration set) is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish CAPA procedures (21 CFR § 820.100(a)):** Health risk assessments, health hazard evaluations, and root cause analyses were not completed within the required 10-day timeframe (e.g., CAPA-00041, CAPA-00047). Root cause analysis for CAPA-00040 (Class I recall RES 90845) was inadequate. Verification of effectiveness for CAPA-00044 (Class I recall RES 91783) was insufficient. 2. **Failure to control device design (21 CFR § 820.30(a)):** Impact assessments for design changes (e.g., ECO-00089, FAI-3552) did not adequately evaluate risks