The FDA today released a warning letter it sent to Cook Medical last month, flagging problems found during inspections of a Bloomington, Ind., plant last summer.
The inspections turned up issues with how Cook accounts for products that are scrapped during the manufacturing process, according to the letter. The Bloomington plant makes vascular implants, intravascular catheters and related systems.
In 1 example flagged by the federal watchdog agency, Cook identified "735,385 nonconformances across all device families" from June 1, 2012 to June 18, 2014, according to the letter.
"[H]owever; you did not evaluate and, where necessary, investigate those nonconformances. Your firm’s evaluation involves associating the nonconformance with a reject definition however, the definitions do not adequately identify the cause of the problem so that it can be addressed," according to the letter.
But it’s unclear what percentage of products that 735,385 number represents over the 2-year span cited by the FDA. The warning letter also flags "nonconformances" found before the products undergo quality control testing that weren’t quantified before the devices were re-worked to fix the problem.
"Nonconformances found prior to quality control inspections are not identified and documented, and therefore, the exact number cannot be quantified. Nonconformances found prior to quality control inspections are routinely taken to the group leader, who takes them to the individual responsible for the nonconformance for reworking. Devices that are reworked in this manner are not documented as nonconformances and are therefore not quantified," the FDA said.
Marsha Lovejoy, global manager of corporate content strategy, told MassDevice.com via email today that the 735,385 the FDA flagged "were nonconformances identified throughout the quality system before they moved forward to be a finished product."
"We manufacture 10s of millions of units a year. The changes requested by the FDA will help us better quantify, identify, and eliminate nonconformances earlier in the manufacturing process," Lovejoy wrote, noting that the nonconformances flagged occur very early in the manufacturing process.
"The changes we are making will help us track products that do not meet quality specifications during the manufacturing process even before they are assessed by our quality control team," she wrote. "Making these changes will require a lot of work and expense on the front end. However, monitoring production processes and identifying inefficiencies earlier should make us more effective. We will use this as an opportunity to improve and raise the bar even higher on our expectations for quality."
Lovejoy said Cook Medical sent in their response to the warning letter Oct. 8.
"The plan and dates met their expectations and we will have most of the requested improvements in place by Dec. 31. Our plan is to go above and beyond the expectations of the FDA," she told us.
