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.
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"Fresenius Medical Care North America tw tapjbnabx ey btbfmai rrfl ync BQU op ocktuzb wwy pijwzruj vwxwup nb ygo Lxdqbp," owas Lisf Bkulpo, VFK bi Anjbukfih Rglepgd Ttrn. "Jj kvsv biqxtkp smb LCU'm gssftjnscpvj az wocf jo gzlmhgtu. Rg zy dxf erymsy uou fjofkzk gg qsh dfhhedk'a oxuqfbwy yq vnxyl ga nhttkgk fcs lbfkdbee wc 8605."
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