Cook Medical announces successful resolution of 2014 FDA warning letter


warningCook Medical has announced that it received a close-out letter from the US Food and Drug Administration (FDA) resolving a 2014 warning letter for processes related to the quality system at the company’s manufacturing facility in Bloomington (Indiana, USA). A company press release states that the resolution was a direct result of the company’s employees’ efforts to improve Cook Medical’s quality system over the last four years.

The 2014 letter issued by the FDA to Cook Medical stated that an inspection “revealed that your firm’s devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”

“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,” says 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. 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.

Yonkman now comments: “As we have 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 are not finished yet, but our teams have worked hard to improve our delivery times, and we thank our customers for sticking with us.

“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 fulfil our mission of improving the lives of patients around the world.”


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