FDA Warns St. Jude Over Production Of Heart Device

Law360, New York (January 14, 2013, 4:51 PM EST) -- St. Jude Medical Inc. announced Friday that it has received a U.S. Food and Drug Administration warning letter alleging it has failed to properly oversee the design and production of a heart device manufactured at a facility in California.

The company said that it had been expecting to receive the letter in light of the agency's investigation of its Sylmar, Calif., facility in September and October and a subsequent report detailing inadequacies in the design process for St. Jude’s Durata defibrillator implant lead. St. Jude added...
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