Регуляторы США осудили крупнейшую компанию по диализу за продажу просроченных и протекающих мешков с раствором

Federal regulators have publicly rebuked one of the world's largest dialysis companies for leaving leaking bags of peritoneal dialysis solution on the market for roughly eight months after its own investigation flagged the problem. The warning letter went to Fresenius Medical Care AG and Co. KGaA, concerns the company's plant in Ogden, Utah, and was posted to the agency's website on September 1, making the internal timeline visible to patients for the first time. The company opened an investigation in August 2025 after a trend of complaints about leaking bags of DELFLEX Dextrose Peritoneal Dialysis Solution. That review eventually counted 35 complaints covering about 156 bags from multiple batches. No recall followed at that point. Agency investigators inspected the Ogden plant in early March 2026, and the recall came the following month. For the tens of thousands of Americans who perform peritoneal dialysis at home, that gap is not an abstraction. Peritoneal dialysis works by running sterile fluid into the abdominal cavity through a permanent catheter, which means a compromised bag is a direct path into the body rather than a spoiled product a patient can simply discard. Inside the Gap Between the Complaint Trend and the Recall The most striking detail in the letter concerns how the company scored its own risk. Fresenius maintains a risk management matrix, and that matrix identified peritonitis as a potential harm and recommended the highest severity level. The company instead assigned the lowest severity level, listing the potential harm as damage of property. The company's own investigation attributed the leaks to holes caused by printing. Its stated reasons for not recalling included the absence of peritonitis cases attributed to the bags, labeling that instructed users to inspect bags for leaks, an expectation that leaks would be caught before treatment, and an assumption that escaping fluid would collect in the outer overwrap. Regulators rejected that reasoning. After the inspection, the company reexamined part of one batch and found perforations in the primary container without substantial fluid present in the overwrap, which undercut the assumption that users could reliably spot a leak. The agency wrote that the decision not to recall at that time exposed peritoneal dialysis (PD) patients to potentially non-sterile drug products. It added that users should not be relied on to detect leaking bags at all, and that once the company knew of a trend in marketed product, its urgency should have risen to match. The letter also flags a compounding factor. Dextrose, a significant component of the solution, could serve as a nutritional source for contaminating microorganisms and promote their growth, so a small breach has room to become a larger problem before anyone notices. For Home Dialysis Patients, the Bag Check Was Never a Safety Net Peritonitis is the complication that shapes daily life for peritoneal dialysis patients. It can require hospitalization, antibiotics delivered through the catheter, catheter removal, and in some cases a permanent switch to in-center hemodialysis. That last outcome reorganizes a household around a treatment schedule. The regulatory finding here is narrower and more useful than a general warning. Regulators concluded that patients and caregivers should not function as the detection system for a manufacturing defect. Inspection instructions on a label were being counted as a control, and the agency said that reasoning does not hold. Patients should not read this as a reason to skip or delay an exchange. Missed dialysis carries immediate and well-documented risk that is considerably larger than the risk described in this letter. The affected lots were recalled in April, and anyone holding supply at home can ask their home dialysis nurse to check lot numbers against the company recall announcement and its companion notice, or search current listings on the agency's recalls and safety alerts page. Anyone who develops cloudy drain fluid, abdominal pain, fever, chills, or nausea during a treatment cycle should contact their dialysis team promptly rather than waiting for a scheduled visit. Those are common early signals of peritonitis, and it responds well to early treatment. A Second Finding Involving Particles in Injectable Products The letter cites a second violation, unrelated to the leaking bags. Regulators found the plant's visual inspection program inadequate to ensure that sterile injectable drug products were essentially free of visible particulates. The specific failure involved training records. The kit used to qualify inspection staff did not include adequately representative particulates, and the qualification records lacked enough detail to establish who was qualified to perform the work. The agency said such kits should typically contain particles in the 100 to 150 micron range to adequately challenge an inspector's detection ability, and asked the company to build the U.S. Pharmacopeia standard for visible particulates into its procedures. Regulators called the company's responses inadequate on both findings. On the leaking bags, the agency said the response lacked a sufficient corrective plan, including better detection of leaking units during manufacturing, and called that especially concerning given numerous complaints, Field Alert Reports, and recalled batches over the previous three years involving leaking large volume parenteral bags at the same site. Two earlier Field Alert Reports involved leaking bags with microbial contamination. Next Steps for Regulators and the Company The letter, signed by Francis Godwin, who directs the Office of Manufacturing Quality within the agency's drug center, gave the company 15 working days to respond in writing. Regulators asked for an independent assessment of the root causes of the leaking bags, an analysis of alternative printing technologies, a review of whether the quality unit has the authority and resources to function, and detailed batch performance summaries covering at least five years. The agency also said the company should engage a qualified consultant to perform a comprehensive six-system audit of its operation before pursuing resolution of its compliance status. That process is described on the agency's page about warning and close-out letters. Unresolved violations can lead to seizure, injunction, withheld export certificates, and withheld approval of new applications listing the facility. One line in the letter deserves attention from patients. Regulators asked the company to contact the drug shortages staff immediately before taking any action likely to disrupt supply of drugs made at the plant. That language acknowledges a real tension in this case, since the same facility that drew the citation also supplies a product some patients depend on daily. Clinicians and patients who encounter a problem with a dialysis product can file a report through MedWatch. MedicalDaily will follow whether the company's response satisfies regulators or draws further enforcement. Key Questions Answered What did federal regulators actually cite? They cited a failure to thoroughly investigate complaints and a failure to establish adequate written production and process controls at the Ogden plant. Those findings make the drug products adulterated under federal law, a designation about manufacturing conditions rather than proof that any specific bag caused harm. Which product is involved? DELFLEX Dextrose Peritoneal Dialysis Solution. The company issued voluntary recalls of affected lots in April 2026 for lack of assurance of sterility, and the agency posted two company announcements. Has anyone been confirmed harmed? No peritonitis case has been attributed to the leaking bags. Regulators faulted the company for treating the absence of an attributed case as evidence that the risk was low. Why did the timeline matter so much to regulators? The company knew about a trend in product already on the market and did not act until after an inspection. The agency said that gap left patients exposed to a solution that might not be sterile. Should patients stop their dialysis? No. Skipping or shortening treatment carries far greater immediate risk. Patients with questions should contact their dialysis team and verify lot numbers rather than change their treatment schedule. What symptoms should patients watch for? Cloudy drain fluid, abdominal pain, fever, chills, or nausea during a treatment cycle warrant a prompt call to the dialysis team. These can indicate peritonitis, which responds well to early treatment. What happens next? The company had 15 working days to respond in writing with corrective plans. Regulators may reinspect the facility, and unresolved violations can trigger seizure, injunction, or withheld approvals. Published by Medicaldaily.com