FDA Issues Warning Letter For Manufacturing Problems at Medtronic CRDM Facility

Medtronic Inc. has received a warning letter from regulators after an inspection of the company’s Cardiac Rhythm Disease Management facility in Mounds View, Minn.

The letter from the U.S. Food and Drug Administration (FDA) said it found problems with corrective and preventive action and field action timeliness; review and documentation of field action recommendations; supplier qualification and controls; and medical device reporting 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 said it will respond to the letter within 15 days and has already started to implement changes. The FDA said the firm’s promised corrective actions appear to be adequate and that it will re-inspect the plant.