Breaches in Supply Chain Security Increase Regulatory Scrutiny of Raw Materials Used in Medical Devices and Pharmaceuticals

Published Jul 29, 2014

Midland, Mich. - A pharmaceutical manufacturer makes an unannounced visit to the plant that produces one of its key raw materials, only to find that the plant doesn’t even exist. A well-known medical device manufacturer has to initiate a global recall of its drug-eluting stent based on reports of a malfunction of the catheter used to deliver the combination product to the proper position within the blocked artery. Elsewhere, a seemingly insignificant raw material change deep in the supply chain negatively impacts end-product performance, threatening patient safety.