Complaint Handling Still Tricky For Many Firms; FDA Offers Tips

摘要

Many device manufacturers do not build effective complaint handling procedures and systems, while others routinely fail to properly investigate product complaints, FDA says."We've had the Quality System Regulation now for 15 years. We said then, in 1996, that we had 18 years of good manufacturing practice experience, yet firms were still having problems when it came to complaint handling," FDA guality system expert Jan Welch said.