The FDA’s observations fall into four general categories: corrective and preventive action (CAPA) and field action timeliness, review and documentation of field action recommendations, supplier qualification and controls and medical device reporting (MDR) timeliness.

“Medtronic remains committed to providing the highest quality products to our customers and 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.

The company 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. 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.