FDA 483 - Medicore Co., Ltd. - November 09, 2023
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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.
ID · b70c25ef-6eb6-4bc2-9ebb-3890474db9e6