Teleflex Turned Around Arrow’s Quality System Following FDA Corporate Warning Letter
This article was originally published in The Silver Sheet
Executive Summary
When an FDA corporate warning letter was sent to Arrow International in 2007 outlining numerous quality system deficiencies, the new owner of the troubled device company knew that drastic steps had to be taken. “This is a story about what can happen to a company, the compliance issues it can become involved in, and more importantly, the steps we took to remediate all of those issues and bring the company back into a healthy compliance mode,” said Michael Crader, VP of global RA/QA at Teleflex. Work to fix Arrow’s quality system began with an analysis of the firm’s data and a shutdown of Arrow plants across the globe. Quality system teams were formed to tackle five key areas: management control, CAPA, production and process control, materials and change management, and design control.