FDA 483 - Exercore, LLC - December 18, 2018

An FDA inspection of Exercore, LLC in Shakopee, MN, revealed significant deficiencies in the firm's quality system for its eustachian tube exerciser. The inspection found a pervasive lack of established procedures across critical areas including design control, corrective and preventive actions, complaint handling, medical device reporting, non-conforming product control, and purchasing controls. These findings indicate a fundamental absence of a robust quality management system.