FDA 483 - McGinley Orthopaedic Innovations LLC - June 05, 2025

McGinley Orthopaedic Innovations LLC in Casper, WY, was inspected by the FDA from June 3-5, 2025. The inspection revealed that the firm's procedures for ensuring equipment is routinely calibrated and checked were not adequately established. This included having five tools with expired calibrations in service and failing to follow its own procedure for a passivation process by lacking necessary controls and a known solution.