Medtronic Inc. (MDT) announced that it received a warning letter from the U.S. Food and Drug Administration regarding the inspection of the Company's Mounds View, Minn. - Cardiac Rhythm Disease Management - facility completed in August 2009. FDA noted in its warning letter to Medtronic that the Company's promised corrective actions appear to be adequate to address the concerns raised in the letter and will be confirmed upon reinspection.
The FDA's observations fall into four general categories: corrective and preventive action and field action timeliness; review and documentation of field action recommendations; supplier qualification and controls; and medical device reporting timeliness.
The company said that it will respond to the letter within 15 days, as required. In addition, the Company has already begun to implement changes and put procedures in place related to each of the observations cited during the inspection, and any additional actions that may be required will be in place as quickly as possible.
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