The German dialysis giant said the U.S. watchdog agency warned it about problems with its design verification and validation procedures at a plant in Ogden, Utah.
The FDA letter asserts that Fresenius "did not conduct adequate design verification studies of its electron beam (E-beam) sterilized polysulfone dialyzers" at the Ogden facility and that "the process for design validation of these dialyzers has been incomplete," according to a press release.
"Fresenius Medical Care North America is committed to working with the FDA to resolve the concerns stated in the letter," CEO Rice Powell said in prepared remarks. "We will address the FDA’s observations as soon as possible. We do not expect any effects on the company’s guidance in terms of revenue and earnings in 2013."