Cook Resolves 2014 FDA Warning Letter
Bloomington-based Cook Medical says it has closed out the process of resolving a 2014 warning letter from the U.S. Food and Drug Administration involving documentation and data collection. Cook says the resolution is the result of "countless hours of hard work by hundreds of people" to improve its quality system.
Cook Group and Cook medical President Pete Yonkman says the feedback from the FDA letter was "tough, but beneficial."
As part of its response, Cook realigned the company's business into Vascular and MedSurg divisions. It is also underway with changes to accelerate the company's product development process and upgrade its IT infrastructure. Cook also says a recently-purchased, million-square-foot factory in Bloomington will give the company the room it needs to redesign its manufacturing process.
"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," said Yonkman in a news release. "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."