FDA 483 - Ki Mobility Llc - September 19, 2025

Ki Mobility Llc in Stevens Point, WI, was inspected and cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for handling customer complaints, including a lack of proper investigation and unclear definitions of investigation processes and roles. Additionally, the firm's corrective and preventive action (CAPA) procedures were found to be insufficient, as recurring product failures did not trigger CAPAs and trend analysis thresholds were undefined.