Fresenius Kabi AG has received a warning from federal health regulators over problems at a Puerto Rico manufacturing plant that makes blood bags.
It was announced on August 26 that the company had received an FDA warning letter on its Fenwal blood bag manufacturing plant in Maricao, Puerto Rico. The letter comes as a result of an April inspection of the facility, but Fresenius says that the warning was not linked to any problems that could affect patient safety or adverse events.
The FDA has not yet published the letter, and the company has a history of downplaying, sometimes dramatically, the content of FDA warning letters before they are publicly released.
According to the company, the warning letter admonishes Fresenius for how it handles complaints, labeling issues and failing to file field alerts in accordance with FDA regulations. The company says it intends to address the issues in a timely manner.
This is at least the third warning letter Fresenius has received this year from the FDA. It received another warning letter last month regarding problems at its generic drug API plant in India. The FDA accused employees of outright lying about quality tests, with one instance of an employee trying to hide test results in his pocket.
Another warning letter issued in March warned of problems with its efforts to study artificial kidneys used in its dialysis machines.
Fresenius Problems with GranuFlo and NaturaLyte Dialysis Treatments
This warning letters come while Fresenius is under close scrutiny following a recall for NaturaLtye and GranuFlo dialysis treatments, which the FDA forced the company to issue after the company warned about an increased risk of cardiac arrest and sudden death during dialysis treatments.
Questions have been raised about whether Fresenius withheld information about the risk of problems during dialysis treatment with Granuflo and NaturaLyte. Although the company sent an internal memo to it’s own clinics in late 2011, they failed to inform medical providers at competing clinics that used their dialysis products about the importance of monitoring patients until March 2012. The FDA classified this warning as a recall.
An increasing number of Fresenius dialysis lawsuits have been filed nationwide on behalf of individuals who suffered heart attacks or lost loved ones to heart problems after dialysis treatment with NaturaLyte and GranuFlo.
All of the lawsuits involve similar allegation, claiming that the company failed to provide adequate warnings about the risk of complications following dialysis when Granuflo or NaturaLyte are used, including the importance of monitoring patients’ bicarbonate levels to avoid a risk of sudden cardiac arrest or death.