FDA closes out Cook Medical manufacturing facility warning letter

Cook Medical said today that the FDA closed out a 2014 warning letter it sent to the company over quality system issues with its Bloomington, Ind.-based manufacturing facilities. The company touted the closure of the warning letter for the plant, which makes vascular implants, intravascular catheters and related systems, and said that it was the result of four years of work to correct and improve its quality systems. The inspections, performed between 2012 and 2014, turned up issues with how Cook accounts for products that are scrapped during the manufacturing process. In one example flagged during its inspections, the federal watchdog identified 735,385 nonconformities “across all device families,” according to the original warning letter. The facility reportedly produces in the tens of millions of units a year, a company representative told MassDevice.com in 2014, noting that the flagged devices were “nonconformance’s identified through the quality system.” Cook Medical said that its efforts to correct the noted issues included re-aligning the company’s businesses into two divisions, vascular and medsurg, as well as upgrading its IT infrastructure and improving and accelerating its product development process. The company said it also recently purchased a million-square-foot abandoned factory in Bloomington as it looks to further redesign its manufacturing process. “Receiving critical feedback from the FDA in 2014 was tough, but benef...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Cook Medical Source Type: news