FDA 483 - EnduroMed - June 17, 2025

EnduroMed, an HCT/P establishment in Brookfield, WI, was inspected by the FDA from June 16-17, 2025. The inspection revealed a significant issue regarding the firm's failure to approve core Current Good Tissue Practice (CGTP) procedures by a responsible person before their implementation. This indicates a fundamental lapse in quality system controls.