Tate Technology failed to properly evaluate complaints or keep records of nonconformances, according to the FDA.
The FDA issued a Form 483 to the devicemaker following a June inspection of its Spokane, Wash., facility. Investigators found the firm’s procedures for handling complaints did not include a requirement that all medical device complaints be evaluated for medical device reporting, and it did not document an MDR evaluation for any of 12 complaints received since last January.
The agency found the company did not keep records of “Red-Tag” nonconformances for medical devices. The facility’s quality manager told investigators that the tags were disposed of as soon as the nonconformance was handled.