U.S. Filter Plant Violates Rules, FDA Says
U.S. Filter Corp.’s facility for manufacturing medical water-purification systems has serious quality control problems, according to a government warning letter sent to the company. The May 27 letter from the Food and Drug Administration came after a February inspection of the company’s Metairie, La., plant turned up flaws in the company’s record keeping and management practices. The Palm Desert-based company makes water-purification systems that filter the water used during hemodialysis, a procedure often used to purify the blood in people whose kidneys can no longer filter away toxins. The inspection of the plant showed there were no procedures in place to ensure that quality and safety issues are consistently addressed. U.S. Filter did not return calls seeking comment. Shares in the company rose 56 cents to close at $31.88 on the NYSE.
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