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The U.S. Food and Drug Administration (FDA) on Tuesday issued a warning letter to Fresenius Medical Care AG & Co. KGaA'sFresenius USA Manufacturing following a March 2026 inspection at its Ogden, Utah production facility.
In a letter to the company's CEO, Helen Giza, Federal regulators determined that the plant committed major Current Good Manufacturing Practice violations, rendering its finished pharmaceutical products adulterated under the Federal Food, Drug, and Cosmetic Act.
Unchecked Dialysis Solution Leaks
FDA investigators found that the facility failed to thoroughly investigate customer complaints involving leaking bags of Delflex Peritoneal Dialysis Solution.
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The plant received 35 complaints covering 156 leaking units linked to printing defects.
Although internal risk protocols classify peritonitis as a severe hazard, the firm improperly categorized the defect as low-severity property damage and avoided immediate recalls.
The company eventually issued voluntary recalls in April 2026 after the federal inspection.
Regulators emphasized that non-sterile solutions expose patients to life-threatening infection risks, especially since dextrose in the solution accelerates microbial growth.
Deficiencies In Visual Inspection Programs
The agency also cited the facility for failing to establish adequate written procedures for process controls.
The plant's visual inspection program failed to verify that sterile injectable products remained free of visible particles.
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Inspector qualification kits lacked representative particulate sizes, missing the critical 100-to-150 micron range required to adequately challenge staff detection capabilities.
Fresenius Requires Consultant Audits And Federal Enforcement
The FDA advised the company to retain an independent expert to perform a full six-system audit and overhaul its quality unit oversight.
The facility must submit comprehensive remediation plans addressing process capability, root cause analyses, and manufacturing line controls.
Regulators warned that failing to address these compliance failures promptly could trigger enforcement actions, including product seizures, court injunctions, and the withholding of export certificates or new drug approvals.
Photo by Tada Images via Shutterstock
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