The US Food and Drug Administration (FDA) has informed Medtronic that issues noted in two warning letters - one from November 2009 regarding the Mounds View, Minnesota facility and another from June 2009 regarding the company’s manufacturing facility in Juncos, Puerto Rico - have been resolved.
Medtronic received an FDA warning letter following an August 2009 inspection of the company’s Mounds View facility, which serves as the headquarters of the Cardiac Rhythm Disease Management business.
The company also received an FDA warning letter following a December 2008 inspection of the company’s facility in Juncos, which is a manufacturing location for the Neuromodulation, Diabetes and Cardiac Rhythm Disease Management businesses.
Medtronic chairman and CEO William Hawkins said they are encouraged that the action plans implemented by their teams have resolved the observations identified by the FDA in both warning letters.
"We will continue to provide the highest quality products and we are actively working to ensure the changes we have made are appropriately incorporated across all of our global facilities," Hawkins said.