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

Source: https://www.keypedia.com/records/483/dexcowin-co-ltd/3e975922-d2df-4660-b378-dec0ac37f108

> FDA 483 for Dexcowin Co. Ltd. on February 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dexcowin Co. Ltd.
- Inspection Date: 2023-02-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

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- [WARNING_LETTER - 2017-08-31](https://www.keypedia.com/records/warning_letter/dexcowin-co-ltd/b389e6b4-c557-4e65-8e6d-30a9a890bc41)
- [483 - 2023-02-23](https://www.keypedia.com/records/483/dexcowin-co-ltd/d736b4a4-441c-4c0f-81be-e242bcba987b)

## Related Officers

- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/dexcowin-co-ltd/95b6ec0f-e5d8-4d7d-8eb8-d5d31e4633c5

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4