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FDA Opposes 2 Grace Dialysis Products. (Originated from The Miami Herald)
Knight Ridder/Tribune Business News, August, 1993 by McNair, James
Aug. 6--A subsidiary of W.R. Grace & Co. of Boca Raton has been barred by the U.S. Food and Drug Administration from importing certain kidney dialysis products because of production violations at Grace plants in Mexico and Ireland.
The two products are used in kidney dialysis centers nationwide, including Grace's own 400-plus clinics nationwide. An FDA spokeswoman said the agency cited the subsidiary, National Medical Care, in June after an inspection of its overseas plants.
"We're not releasing the specific details, but generally speaking, there were serious problems with good manufacturing practices," said FDA spokeswoman Sharon Snider. "They were not just paper problems, but violations of procedure that truly could affect the quality and safety of these...
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