FDA Weighs St. Jude's Promise Of Durata Production Fixes

Law360, New York (January 9, 2013, 3:50 PM EST) -- The U.S. Food and Drug Administration said Wednesday it is reviewing St. Jude Medical Inc.'s plan to strengthen its quality control system after the agency alleged the company failed to properly oversee the design and production of a heart device.

In November the FDA released a report that detailed inadequacies in the design process for St. Jude’s Durata defibrillator lead uncovered during the inspection of the company’s Sylmar, Calif., facility in September and October.

“We recognize and take seriously the [FDA’s] observations ... and are committed...
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