FDA tells Fresenius Medical to improve dialyzer production
FRANKFURT, March 14
FRANKFURT, March 14 (Reuters) - Dialysis specialist Fresenius Medical Care said U.S. regulators had told it to improve the way it sterilizes certain dialyzers for filtering patients' blood.
The Food and Drug Administration (FDA) issued a warning letter to Fresenius Medical Care, saying that the process for design validation of these dialyzers, produced in Ogden, Utah, was incomplete, the German group said on Thursday.
The warning letter would not affect its sales and profit outlook for 2013 and the FDA did not impose a product recall, Fresenius added.
The dialysis company said it had confidence in the quality of the products produced in Ogden and that it would work with the FDA.