FDA 483 - Cognivue Inc. - August 15, 2022

An FDA inspection of Cognivue Inc., a medical device manufacturer in Victor, NY, revealed two repeat observations concerning quality system deficiencies. The firm failed to adequately establish procedures for controlling nonconforming products, including proper investigation and identification. Additionally, procedures for device history records were not adequately established, specifically regarding the inclusion of primary identification labels for Cognivue Thrive devices.