Medtronic resolves FDA warnings over 2 facilities
Sunday, March 13, 2011
WASHINGTON (AP) — Medtronic Inc., the world’s largest medical device company, said Wednesday it has resolved two warning letters from the Food and Drug Administration over lax oversight at two facilities, clearing the way for new product approvals.
The FDA cited the company in November 2009 and June 2009 over problems at facilities in Mounds View, Minn., and Juncos, Puerto Rico.
The violations involved unsatisfactory procedures for preventing and identifying problems with its devices, documenting those problems and notifying the FDA.
The FDA typically withholds approval of new products when there are outstanding problems at a facility where they would be manufactured. The Mounds View facility houses Medtronic’s heart rhythm product unit, its largest business by sales. The warning letter there has held up the approval of several critical devices, including a next-generation defibrillator Protecta.
The Puerto Rico facility manufactures diabetes, neurological and heart devices.
Leerink Swann analyst Rick Wise said Medtronic could bring several new products to market from the facilities by the end of the summer.
The warning letters have been one of several negative factors pressuring the company’s stock the last several years. In 2007 the company issued a high-profile recall of wires used with its defibrillator implants due to a problem that could cause them to break and fail. Two years later the company recalled thousands of pacemakers due to a defect that made some of them unresponsive or run out of battery power.
Last month the company announced it would lay off up to 2,000 workers as part of a restructuring effort to make up for anemic sales of its implants.
The company’s chief executive, Bill Hawkins, is scheduled to step down in April after three years leading the company.