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www.fdanews.com/articles/81430-fda-warns-tyco-over-device-production

FDA WARNS TYCO OVER DEVICE PRODUCTION

October 5, 2005

The FDA recently warned Tyco International about the company's failure to quickly tell the agency about possible problems with certain devices.

In a recent warning letter, the FDA chided Tyco for failing to submit Medical Device Reporting reports within 30 days of becoming aware that some of its devices may have caused or contributed to a death or serious injury. The letter, made public Oct. 3, also argues that the company did not maintain distribution records for its devices, ensure that these products followed design specifications, or properly review complaints about some products.

The company will work with the FDA to resolve the problems and will contract with outside consultants to review quality issues, Shay Studley Toland, a spokeswoman for Tyco said.