Cook Medical Resolves 2014 FDA Warning Letter

Cook Medical today announced that it received a close-out letter from the U.S. Food and Drug Administration resolving a 2014 warning letter for processes related to the quality system at the company’s manufacturing facility in Bloomington, Ind. The resolution was a direct result of countless hours of hard work by hundreds of people at Cook over a four-year period to improve the company’s quality system.
 
“Receiving critical feedback from the FDA in 2014 was tough, but beneficial. After a lot of thoughtful discussion, our leadership team decided this feedback was an opportunity to slow down and take a hard look at our company,” said Pete Yonkman, president of Cook Group and Cook Medical. “As a result, we established a plan to not only address the issues in the warning letter, but transform our entire company.”
 
A key part of that transformation was the recent realignment of the company’s business into two divisions, Vascular and MedSurg, to better meet the needs of customers. Other critical changes that are underway include improvements to accelerate the company’s product development process, to elevate the level of customer service and to upgrade the company’s IT infrastructure. Cook also recently purchased a million-square-foot abandoned factory in Bloomington to provide room to redesign its manufacturing processes.
 
“As we’ve focused on resolving the warning letter and improving our company over the last four years, we have, at times, disappointed our customers. For example, adding new systems slowed our production capabilities, and we experienced shipment delays. We aren’t finished yet, but our teams have worked hard to improve our delivery times, and we thank our customers for sticking with us,” Yonkman continued.
 
“One of the benefits of being a family-owned, privately held company is that we were able to take the long view and invest in our company and our employees. We still have work to do, but we are proud of the progress our employees have made to get us to this important milestone. Our transformation is making us a better, stronger company so that we can continue to fulfill our mission of improving the lives of patients around the world.”