FDA 483 - MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. - July 12, 2018

Modern Medical Equipment Manufacturing LTD in Hengli, China, was inspected by the FDA from July 9-12, 2018. The inspection revealed significant deficiencies in complaint handling, CAPA management, stability studies, and various aspects of design control for their disposable electrode products. The findings indicate a need for comprehensive improvements in their quality system.