FDA WARNING_LETTER - Fresenius Medical Care AG & Co. KGaA - March 06, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Fresenius Medical Care AG & Co. KGaA following an inspection of its Ogden, Utah manufacturing facility from March 2 to 6, 2026. The inspection identified serious deviations from Current Good Manufacturing Practice (CGMP) regulations, leading the FDA to classify the company’s drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations centered on the company’s failure to adequately investigate product defects and customer complaints. Specifically, Fresenius mismanaged a trend of leaking bags in its Delflex Peritoneal Dialysis Solution. Despite identifying that leaks could lead to life-threatening peritonitis, the company initially categorized the risk as mere property damage and delayed a necessary recall until after the FDA inspection. Furthermore, the FDA found the facility’s visual inspection program for injectable drugs to be insufficient. The company failed to properly qualify personnel because the test kits used to detect contaminants did not include representative or sufficiently small particulates to ensure safety. To address these issues, the FDA requires Fresenius to provide a comprehensive remediation plan. This must include an independent assessment of the root causes of the leaking bags, an evaluation of the Quality Unit’s authority and resources, and a complete overhaul of the systems used for investigating deviations and complaints. Additionally, the company must hire an independent consultant to audit their operations and ensure ongoing compliance. Fresenius is required to respond within 15 working days detailing their corrective actions to prevent the recurrence of these safety and quality failures.