Dexcowin Co. Ltd.February 23, 2023

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

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Record Details

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.

Company: Dexcowin Co. Ltd.
Inspection Date: February 23, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations
Person: Alexandria L. Capuano (Investigator)

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ID · 3e975922-d2df-4660-b378-dec0ac37f108