FDA 483 - Dexcowin Co. Ltd. - February 23, 2023

An FDA inspection of Dexcowin Co. Ltd. in Geumcheon-gu, Seoul, Korea, revealed a significant deficiency in the firm's complaint handling procedures. The company failed to adequately establish and follow procedures for receiving, reviewing, and evaluating complaints, specifically regarding a complaint about portable x-ray devices that was not properly recorded or analyzed. This indicates a lapse in quality system compliance.