Fresenius Medical Care is responding to a U.S. Food and Drug Administration (FDA) warning letter following a March 2026 inspection. The inspection targeted the company's manufacturing facility in Ogden, Utah. Regulators cited major violations of Current Good Manufacturing Practices.
The FDA found that Fresenius failed to thoroughly investigate customer complaints regarding leaking Delflex Peritoneal Dialysis Solution bags. The company initially categorized these leaks as low-severity issues. This classification occurred despite the potential for peritonitis, a life-threatening infection.
Fresenius initiated a voluntary product recall in April 2026 following the inspection. The FDA now requires the company to hire an independent consultant to overhaul its quality control systems. Failure to resolve these violations may result in further enforcement actions, including product seizures.