Cook Medical Resolves Quality System Issues From 2014

The FDA sent Cook Medical a close-out letter that resolved a warning letter the agency issued in 2014 regarding the firm’s quality system.

It took the medical device manufacturer four years to improve its quality system to a level that warranted the agency’s close-out letter, and it is still initiating some changes.

The firm’s changes include splitting the company into two divisions to provide better customer service, improvements to the product development process, IT infrastructure upgrades and the purchase of a large factory to overhaul its manufacturing processes.