FDA 483 - Cogmedix, Inc. - March 07, 2022

Cogmedix, Inc. in West Boylston, MA was inspected from March 2-7, 2022, revealing a significant concern regarding quality control. The firm failed to adequately investigate and evaluate the potential adverse effects on medical device quality when test and measurement equipment was found to be malfunctioning or not meeting specified accuracy and precision limits. This indicates a lapse in ensuring device quality and safety.