The US FDA has warned Fresenius Medical Care over significant cGMP violations at its drug manufacturing facility in Ogden, Utah, including recurring leaks in sterile peritoneal dialysis solution bags.
The FDA inspected the Fresenius Medical Care North America Ogden Plant from 2-6 March 2026 and said the facility's manufacturing methods, facilities and controls did not conform with cGMP requirements for finished pharmaceuticals under 21 CFR Parts 210 and 211.
The regulator's most serious finding concerned the company's investigation of leaking bags of Delflex Peritoneal Dialysis Solution.
Fresenius initiated an investigation in August 2025 after receiving a trend of complaints relating to leaking bags.
The investigation ultimately identified 35 complaints involving about 156 bags from multiple batches, with the company attributing the leaks to holes caused by printing.
However, the FDA said Fresenius assigned the lowest severity level to the issue, even though its own risk management matrix identified peritonitis as a potential harm and recommended the highest severity level.
The company did not initially recall the affected batches, although it subsequently initiated a recall in April 2026.
According to the FDA, the decision potentially exposed peritoneal dialysis patients to non-sterile drug products, which could increase the risk of peritonitis and potentially serious or life-threatening complications.
The agency also highlighted numerous complaints, Field Alert Reports and recalls involving leaking large-volume parenteral (LVP) bags manufactured at the site during the previous three years, including two reports involving microbial contamination.
FDA demands wider action
The FDA has now called for an independent assessment of the root causes of the leaks, including Fresenius' printing technology, equipment and personnel handling.
It has also requested assessments of alternative printing technologies, leak-detection methods, equipment qualification, process capability and statistical process control.
The agency separately found deficiencies in Fresenius' visual inspection programme for sterile injectable products, including inadequate qualification of inspection personnel and insufficiently representative particulate challenge kits.
The FDA warning also comes shortly after Fresenius Kabi recalled one lot of its Tyenne (tocilizumab-aazg) injection in the US.
On 10 August, the company said an internal investigation had identified glass particles in 400 mg/20 mL vials, prompting a nationwide recall.
The company warned that injectable glass particles can cause local irritation and, in serious cases, vascular blockage, pulmonary embolism, organ damage or death.
While the two events concern different Fresenius businesses and products, the close timing to the new FDA warning letter could prompt customers to look more closely at the Group's wider manufacturing and quality-control systems.
The FDA has requested a written response within 15 working days and warned that failure to adequately address the violations could result in further regulatory or legal action, including seizure or injunction.
