FDA Hits 12 Medtech Firms With Warning Letters
The FDA today published the warning letters it sent recently to 12 medical device companies in the U.S. and overseas for violations found during recent inspections.
The federal safety watchdog’s inspectors found a variety of problems at the companies’ plants, ranging from inadequate design control procedures to problems with the way they track and report adverse events. The firms make a variety of products, including electro-surgical and laser surgery instruments, orthopedic implants, surgical drapes and gowns, teeth whitening devices, dental floss and compression socks:
The federal safety watchdog’s inspectors found a variety of problems at the companies’ plants, ranging from inadequate design control procedures to problems with the way they track and report adverse events. The firms make a variety of products, including electro-surgical and laser surgery instruments, orthopedic implants, surgical drapes and gowns, teeth whitening devices, dental floss and compression socks: