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Medtronic responds to warning letter

This article was originally published in The Gray Sheet

Executive Summary

The firm is preparing a response to a recent FDA warning letter relating to an August inspection of its Cardiac Rhythm Disease Management facility in Mounds View, Minn. Medtronic says 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 put in place as quickly as possible." The letter notes deficiencies in corrective and preventive action and field action timeliness; review and documentation of field action recommendations; supplier qualification and controls; and medical device reporting timeliness. According to Medtronic, FDA's letter acknowledges that the firm's promised corrective actions appear adequate to address the agency's observations. The firm previously received a warning letter in June addressed to its Juncos, Puerto Rico, facility related to quality system regulation and medical device reporting issues (1"The Gray Sheet" June 29, 2009)

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