FDA warns Fresenius over dialysis device design measures
The German company disclosed the letter this week, referring to electron beam sterilized polysulfone dialyzers it manufactures at an Ogden, UT, plant. At issue: The FDA asserts that the company didn't sufficiently verify design studies for the product and also noted the design validation process itself "has been incomplete."
Fresenius is quick to note, however, that the warning letter doesn't involve a product recall. That said, company CEO Rice Powell said in a statement that it will work with regulators to resolve all of their issues and "address the FDA's observations as soon as possible."
The product at issue has had FDA clearance since December 2000, Fresenius notes, and the company added that it doesn't expect the warning letter will harm revenue or earnings guidance for 2013.
Fresenius had been arguably the biggest producer of kidney dialysis devices, though it recently saw its position usurped by Baxter ($BAX) after its $4 billion acquisition of Gambro AB, which blended the second and third largest makers of kidney dialysis equipment into a single goliath.
- here's the Fresenius release