FDA 483 - Medicore Co., Ltd. - November 09, 2023

Medicore Co., Ltd., a Class II device manufacturer in Seongnam, Gyeonggi, Korea, was cited with five observations during an FDA inspection from November 6-9, 2023. The inspection revealed significant deficiencies in quality system procedures, including inadequate complaint handling, non-conformance control, acceptance activities, device history records, and employee training. These issues indicate a systemic lack of robust quality management for their Max Pulse device.