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

Source: https://www.keypedia.com/records/483/dexcowin-co-ltd/d736b4a4-441c-4c0f-81be-e242bcba987b

> FDA 483 for Dexcowin Co. Ltd. on February 23, 2023. Product: devices. 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: devices
- Office Name: Baltimore District Office
- Summary: Between February 20, 2023, and February 23, 2023, the U.S. Food and Drug Administration (FDA) conducted a site inspection of Dexcowin Co. Ltd., a medical device manufacturer based in Seoul, South Korea. The inspection identified significant deficiencies in the firm’s quality management processes, particularly regarding the handling of product complaints. The primary violation involved the failure to formally document and investigate a serious complaint received in 2019 concerning Class II portable x-ray devices (models DX-7017 and DX-7020). The complaint highlighted critical safety and quality issues, including incorrect or removable labeling for safety-critical focal spots and highly inconsistent radiation exposure values. Despite internal procedures requiring formal logging and corrective action, the firm failed to record this information in its official ledger, keeping the communication only in an email folder. Management stated the omission occurred because the units involved were demonstration models rather than customer-purchased products. These findings were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic (FD&C) Act. To achieve compliance, Dexcowin Co. Ltd. is required to establish more robust procedures for complaint evaluation and must implement corrective and preventive actions. The firm is expected to respond to the FDA with a detailed plan addressing these observations and must conduct internal self-audits to ensure their quality systems meet regulatory expectations.

## Related Documents

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## 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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa