The U.S. Food and Drug Administration has warned international medical giant Fresenius Medical Care (FMC) to improve its operations and standards at a blood-bagging facility in Puerto Rico. The FDA’s complaints dealt specifically with the facility’s labeling procedures and how it was dealing with customer complaints.
Fresenius has been in trouble with the FDA before, particularly concerning its recalled dialysis concentrates GranuFlo and NaturaLyte. The products were linked to severe adverse events, but FMC did not disclose that information to the FDA until the administration received a leaked internal Fresenius memo detailing the risks.
GranuFlo and NaturaLyte have been linked to sudden cardiac arrest, stroke and other severe complications, according to the memo. Several patients have filed GranuFlo lawsuits alleging the company acted negligently after nearly 1,000 patients suffered GranuFlo side effects in their dialysis clinics.
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