"Medical device manufacturer Medtronic Corporation and two of its top executives have agreed to resolve allegations that they violated various provisions of the federal Food, Drug and Cosmetic Act (FDCA) with regard to the company’s SynchroMed infusion pump. At the request of the U.S. Food and Drug Administration (FDA), the Justice Department today filed a complaint and a proposed consent decree in the U.S. District Court for the District of Minnesota. The complaint alleges that Medtronic, its chief executive officer, S. Omar Ishrak, and its senior vice president, Thomas M. Tefft, have been distributing medical devices in interstate commerce that are adulterated because they were not manufactured in accordance with current good manufacturing processes." Full article »