Another Fresenius Warning, This Time Over Puerto Rico Plant

fresenius_puerto_rico_plantThe U.S. Food and Drug Administration just issued a third warning to German health care group, Fresenius.

The federal regulators have warned Fresenius to improve procedures at its sites; this time, the warning concerned its manufacturing plant in Puerto Rico where blood bags are made, according to Reuters. The FDA mentioned the way in which Fresenius handles complaints and labeling. Fresenius said that it is addressing the agency’s concerns and the site remains operational.

Last month, Fresenius received another FDA warning letter over an inspection of its cancer drug plant, which is located in Kalyani, India, according to Reuters. In March, Fresenius Medial Care, a subsidiary of Fresenius and the world’s largest dialysis company, was advised by the agency improve how it sterilizes some of its dialyzers for filtering patients’ blood, according to Reuters. Also, in May and June, Fresenius Kabi recalled some magnesium sulphate and benztropine mesylate injections in the United States over the potential presence of glass particles in the products’ vials.

We previously wrote that a dialysis center owned by Fresenius Medical Care North America shut down following infection-related deaths and hospitalizations.

A March 15, 2012 inspection revealed that a center failed to meet a variety of infection control standards, among other issues. “Based on the observation, facility policy review and staff interview, it was determined the facility failed to ensure the patient care staff wore gloves and washed hands appropriately during patient care,” according to the inspection conducted by the state health department for participation in the Medicaid and Medicare programs. The deficiencies, according to the report, “had the potential to affect all patients served by the facility.” Eleven other Fresenius dialysis centers in Alabama, alone, were cited with deficiencies over a two-year period in these health department surveys.

Recent lawsuits accuse Fresenius Medical Care of deliberately concealing potentially fatal problems with its now-recalled GranuFlo and NaturaLyte products, which are approved to lower the acidity of patients’ blood during dialysis treatments. The lawsuits allege that patients’ treated with these products tested with a high concentration of acetone, which led to abnormally high levels of bicarbonate in their blood. This led to fatal heart problems and strokes, according to prior court documents.

A judicial panel recently decided that the lawsuits will be consolidated into a federal court hearing. Fresenius Medical Care now faces hundreds of claims; many more are expected. Massachusetts is the chosen venue.

Last June, the FDA deemed a GranuFlo and NaturaLyte recall a Class I, warning that the products, which received agency approval in 2003, may lead to high levels of bicarbonate in patients undergoing hemodialysis when inappropriately prescribed. The agency said that these increased levels can lead to metabolic alkalosis, a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. If not appropriately treated, cardiopulmonary arrest may occur. A Class I recall is the agency’s most serious designation and indicates that the recalled product may cause serious adverse health consequences, including death.

According to court documents, more than 300 lawsuits have been filed nationwide and more are expected, WickedLocalWaltham reported. Despite the Class I designation, the agency did not suggest changes to the way in which GranuFlo is produced and its clearance to market remains in place.

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