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FDA Continues to Caution Fresenius

The FDA has sent another stern warning to Fresenius, this time in reference to the way complaints are handled at the pharmaceutical company’s Puerto Rico plant where blood bags are manufactured. This is the third such warning sent to FMC this year.

Just last month, the FDA issued a warning letter to the Germany-based company after problems were identified during an inspection of the company’s Kalyani, India plant where cancer drugs are made.

In March, Fresenius Medical Care, a subsidiary of the pharmaceutical giant and the world’s largest supplier of dialysis products, was chastised by the FDA for inadequate sterilization of some dialyzers which help to filter the blood of patients with kidney problems.

Fresenius made the news in May and June when the company issued a voluntary recall in the United States for some magnesium sulfate and benztropine mesylate injections after suspicions arose that some vials may contain glass particles. Company reps state that this issue is not expected to affect full-year earnings targets for the Kabi unit.

According to an article in Rueters, Fresenius is working to address the concerns the FDA raised for its Puerto Rico facility.

A number of individuals have filed personal injury lawsuits against Fresenius after suffering heart attacks or the loss of a loved one resulting from dialysis treatment where the company’s GranuFlo or NaturaLyte products were used. For more information about Fresenius dialysis lawsuits, contact an experienced attorney at Berkowitz and Hanna LLC.