St. Jude Resolves FDA Warning for Sylmar FacilityWednesday, July 2, 2014
St. Jude Medical Inc. received notice from the U.S. Food and Drug Administration that it has addressed issues at the company’s Sylmar manufacturing facility outlined in a warning letter received last year.
The St. Paul, Minn. medical device company was encouraged by the resolution of the warning letter, officials said.
Originally the FDA sent the warning letter in January 2013 to the Cardiac Rhythm Management Division of St. Jude, which makes surgically implanted defibrillators and pacemakers. The letter outlined that the methods St. Jude used in Sylmar to manufacture, pack, store or install its medical devices did not conform with current good manufacturing requirements. The letter did not indicate there were any performance problems or any recalls for the devices.
“(We) will continue to work to ensure the highest standards are met across our manufacturing facilities,” Chief Executive Dan Starks said in a prepared statement.
St. Jude employs more than 1,000 workers at its Valley location.