FDA 483 - Electro Cap International Inc - March 01, 2024

Electro Cap International Inc. in Eaton, OH, was inspected by the FDA from February 27 to March 1, 2024. The inspection revealed that the firm failed to document and adequately maintain acceptance activities, specifically quality verification tests, for their Electrode, Cutaneous Electro-Cap device. This indicates a significant lapse in their device history record keeping and final inspection procedures.