Medtronic resolves 2 FDA warnings

Associated Press / March 10, 2011

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WASHINGTON — Medtronic Inc. said yesterday it has resolved two warning letters from the Food and Drug Administration over lax oversight at two manufacturing plants, 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 devices.

The Puerto Rico facility manufactures diabetes, neurological, and heart devices.

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.