FDA 483 - Neurolign USA, Llc - July 02, 2019

Neuro Kinetics, Inc. in Pittsburgh, PA, a medical device manufacturer, was cited by the FDA for several quality system deficiencies. The inspection revealed inadequate design validation for pediatric use of their Neuro-Otologic Test Center system and a lack of established acceptance criteria for these validation activities. Additionally, the firm's procedures for controlling non-conforming product and for the acceptance of incoming materials were found to be inadequately established.