FDA 483 - Bradshaw Medical, Inc. - February 28, 2022

Bradshaw Medical, Inc. in Kenosha, WI, a medical device contract manufacturer, was inspected and cited for three significant issues. These included inadequate procedures for acceptance activities related to device durability testing, failure to submit a timely Medical Device Report (MDR) for a malfunctioning orthopedic device, and not reporting a field corrective action for devices with incorrect materials to the FDA. Two of the three observations were repeat findings from a previous inspection.