The Food & Drug Administration warned Fresenius Medical Care Holdings Inc. on the company’s failures to keep two of its kidney-dialysis products safe for use.
In a Sept. 15 letter, the FDA listed the company’s inadequate safety procedures involving both the investigation of and remedy for its Liberty Cycler sets and Naturalyte Acid Concentrate products. The watchdog agency also said the company’s manufacturing facilities do not comply with FDA standards.
The FDA sent the letter after its June 15 through Aug 5, 2010 inspection of Fresenius Medical Care‘s Waltham, Mass., facility.
The agency said the company had investigated 118 complaints about leaks in its Liberty products, but after finding safety issues didn’t do anything to address the problem in units already on the market. The FDA said Fresenius only went so far as to find the cause of the problem and stop shipping existing inventory.
The FDA said the company also inadequately investigated two complaints about patient reactions to the Naturalyte Acid Concentrate product. One of the complaints involved a patient losing consciousness and requiring CPR.