Fresenius Medical Care North America (FMCNA) announced today that it has received a warning letter from the Food and Drug Administration (FDA), asserting that the organization did not conduct adequate design verification studies of its electron beam (E-beam) sterilized polysulfone dialyzers manufactured at its facility located in Ogden, UT and that the process for design validation of these dialyzers has been incomplete. FMCNA received FDA clearance for this product in December 2000. The warning letter does not impose a product recall. FMCNA has continued confidence in the quality of products that are produced in Ogden.

"Fresenius Medical Care North America is committed to working with the FDA to resolve the concerns stated in the Letter," said Rice Powell, CEO of Fresenius Medical Care. "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."


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