# FDA 483 - Dexcowin Co. Ltd. - August 31, 2017

Source: https://www.keypedia.com/records/483/dexcowin-co-ltd/bd3b638c-c86a-4044-9950-84fe20fc3164

> FDA 483 for Dexcowin Co. Ltd. on August 31, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dexcowin Co. Ltd.
- Inspection Date: 2017-08-31
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Posdion Co. Ltd. in Seoul, Korea, a manufacturer of portable X-ray systems, from August 28-31, 2017, revealed extensive deficiencies across its quality system. The firm lacked adequately established procedures for critical areas such as design validation, process validation, software validation, corrective and preventive actions, complaint handling, purchasing, servicing, device history records, training, document control, management review, and quality audits. Furthermore, the company failed to report an accidental radiation occurrence as required.

## Related Documents

- [WARNING_LETTER - 2017-08-31](https://www.keypedia.com/records/warning_letter/dexcowin-co-ltd/b389e6b4-c557-4e65-8e6d-30a9a890bc41)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-m-simpson/3c0113ae-d846-4e37-aafa-13d58c465fa3)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd