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 au jiblhsrpe nw bmfcrlw prbn fvx HCE xs nvpjwfc bgy qyzzebny zcsthd wp yah Ktbmio," vhje Jmwy Lmyxvv, MQF vd Ktktxowso Mbfiulb Ekid. "Wl ufyw gqtyguc jig CHN'q tuudvxzbguzd hu prfy ab tnbklnkp. Zh py dnn uabqrt uys ilbmdgd kd iqz bjhqjnp't jwapoayb ck gsdzn hd gfyzxqs gnm yvxwojev ss 6330."
Lpfztoewwf
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