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FDA says Fresenius did not properly verify dialyzer designs in Utah plant

March 14, 2013
KEYWORDS FDA / fresenius
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Fresenius Medical Care North America has received a warning letter from the U.S. Food and Drug Adminstration that says the organization did not conduct adequate design verification studies of its electron beam (E-beam) sterilized polysulfone dialyzers manufactured at its Ogden, Utah plant.

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