Cook Medical Resolves 2014 FDA Warning Letter


September 11, 2018—Cook Medical announced it has received a close-out notification from the US Food and Drug Administration, resolving the warning letter issued to the company in September 2014. The warning letter pertained to device manufacturing processes at Cook's Bloomington, Indiana, facility, but it ultimately led to widespread changes throughout the company.

“Receiving critical feedback from the FDA in 2014 was tough, but beneficial," commented Pete Yonkman, President of Cook Group and Cook Medical, in the announcement. Providing more details on the resolution and its effects at Cook to Endovascular Today, Mr. Yonkman explained how the FDA's warning letter spurred the company to examine all of its processes from top to bottom.

"It was an opportunity for us to reflect and make sure we were on the right path to where we wanted to be as a company, to make sure we served our customers and their patients," said Mr. Yonkman. Some internal systems had become dated, he continued, and with new facilities and departments being added over the years, the company needed a clearer look at how all of its divisions fit together.

While working to address the issues cited by the FDA, Cook's management team began soliciting feedback from its own employees as to which company practices needed to change and which needed to be preserved—engaging approximately 10,000 employees in the exercise. Coupling this feedback with that of its customers, Cook then initiated a 5-year "transformation" plan, a core component of which was clearing the FDA warning letter. Another key element of the plan was a major reorganization that saw 10 business units converted into two primary divisions—MedSurg and Vascular—earlier this year.

Mark Breedlove, Vice President of the Vascular division, noted that a key restriction levied under the FDA warning letter is that no premarket approval applications for class III devices could be approved until the company satisfactorily resolved the concerns cited by the agency. With the resolution in place, Cook's Vascular group aims to move forward with premarket approval applications for two devices. In the wake of the warning letter, Cook reassigned some of its engineering teams to help with the transformation, and the R&D teams have now been realigned and a new Vice President of R&D brought in. The company is focusing on new ways to partner with other companies, including acquiring new technologies, in addition to its internal product development and innovation efforts.


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