FDA 483 - LivaNova USA, Inc. - May 04, 2021

An FDA inspection of LivaNova USA, Inc. in Houston, TX, revealed a significant deficiency in process validation for its Model 105 and Model 106 Generators. The firm failed to adequately validate a critical manufacturing process, including omitting operational qualification and having insufficient acceptance criteria. This lapse in quality system procedures has resulted in ongoing field corrections for affected devices.