Fresenius, the German drug company and manufacturer of the dialysis product GranuFlo, received another letter from the FDA warning that the practices at its facility failed to adhere to safety standards. This is the second such letter that a Fresenius subsidiary received this year.
Earlier this year the FDA issued a letter to a Fresenius subsidiary located in India warning them that practices at the plant failed to prevent and detect problems with quality of their product. The warning letter is available in full here.
The most recent warning letter was sent to a Fresenius subsidiary located in Puerto Rico. The warnings to the Puerto Rico manufacturer include concerns over marketing related to the mislabeling of a product or its labels, notification that the offenses have been repeatedly documented and that their failure to adhere to the standards outlined by the FDA can potentially result in the distribution of blood products that are not in compliance with regulatory specifications. The recent warning letter is available in full here.
“Fresenius has established a history of substandard oversight and failure to warn consumers about the dangers associated with its products,” commented Christopher Paulos, a granuflo lawsuit attorney with the Levin, Papantonio law firm who practices in the areas of personal injury and product liability litigation. “Fresenius is one of the nations largest dialysis center operators. Yet, despite being aware of the hazards related to its product GranuFlo, the company notified only its clinics and chose to put its own profits ahead of patient safety.”
GranuFlo is a product that was used in dialysis procedures and has been found to contribute to a dramatic increase in the risk of patients suffering cardiac arrest and sometimes even sudden cardiac death. The company has said that it did not feel that it was necessary to give notice because their internal memo did not contain specific reports related to GranuFlo. The FDA’s warning does not involve GranuFlo.
“Placing patients at risk, instead of notifying them of the dangers associated with a product is a potentially dangerous way to do business,” Mr. Paulos continued. “Unfortunately, it’s one that Fresenius seems to be making its standard practice.”