The FDA has sent Medtronic a warning letter, regarding the inspection of the company’s cardiac rhythm disease management facility in Mounds View, Minn., which was completed in August.
The agency observed four areas of concern, including corrective and preventive action and field action timeliness; review and documentation of field action recommendations; supplier qualifications and controls; and medical device reporting timeliness.
The Minneapolis-based company will respond to the letter within 15 days, as required. Medtronic also said that it 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.
The FDA noted in its warning letter that Medtronic’s promised corrective actions appear to be “adequate” to address the concerns raised in the letter, and will be confirmed upon re-inspection.
Medtronic is “working with FDA to resolve all remaining issues as quickly as possible,” said Pat Mackin, president of the cardiac rhythm disease management business and senior vice president at Medtronic.