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Medical Device Co. Receives FDA Warning

Law360 (February 21, 2007, 12:00 AM EST) -- Edwards Lifesciences Corp., which makes artificial heart valves, may face product approval delays after being scolded by the U.S. Food and Drug Administration over conditions at its California plant.

Edwards said Tuesday that it had received a warning letter from the Los Angeles District Office of the FDA following an inspection of its facility in Irvine that concluded in August 2006. The FDA showed particular concern over the company’s quality systems, including complaint handling, documentation and quality systems training.

"We are fully committed to continual improvement...
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