Fresenius Kabi USA, LLC – FDA 483, Sep 7, 2023

Fresenius Kabi USA, LLC in North Andover, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, design changes, and risk analysis, leading to product issues and recalls. Additionally, the firm failed to report a device correction to the FDA and did not submit required Medical Device Reports (MDRs) for malfunctions that resulted in a Class I recall.