FDA 483 - Fresenius Kabi USA, LLC - August 08, 2025

Fresenius Kabi USA, LLC in North Andover, MA, received a Form FDA 483 for significant deficiencies in its quality system related to the Ivenix Infusion System. The inspection revealed inadequate procedures for corrective and preventive actions, design input, design validation, and design changes, with several issues being repeats from previous inspections. These deficiencies led to potential delays in therapy and pump malfunctions, indicating a moderate to severe risk to patient safety.