FDA 483 - Clarus Medical, Llc - May 22, 2025

Clarus Medical, Llc in Minneapolis, MN, was inspected by the FDA from May 19-22, 2025, resulting in three observations. The inspection revealed significant issues with the firm's quality system, specifically regarding design change procedures, risk analysis, and the control of nonconforming products. These findings indicate a need for improved adherence to regulatory requirements for medical device manufacturing.