Medtronic letter to FDA objects to warning letter's implication of corporate-wide distribution problems.
This article was originally published in The Gray Sheet
Executive Summary
MEDTRONIC CHALLENGES FDA IMPLICATION OF CORPORATE-WIDE DISTRIBUTION PROBLEMS in a March 24 letter to the agency. The firm issued the correspondence in response to a March 10 FDA warning letter that cited Medtronic's Minneapolis-based Neurological Division for good manufacturing practice violations in the assembly and shipment of the Synchromed implantable drug infusion pump. The company says FDA's warning letter wrongfully implies that there are systematic defects in Medtronic's shipping processes.