# FDA 483 - Dana Medical Co., Ltd - April 06, 2023

Source: https://www.globalkeysolutions.net/records/483/dana-medical-co-ltd/823892e8-a26b-48a4-af4d-91fc5ad8cf39

> FDA 483 for Dana Medical Co., Ltd on April 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dana Medical Co., Ltd
- Inspection Date: 2023-04-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Dana Medical Co., Ltd, a medical device manufacturer in Jangseong-gun, Korea, was inspected by the FDA from April 3-6, 2023. The inspection revealed significant deficiencies in their quality system, specifically concerning complaint handling, corrective and preventive actions, nonconforming product control, and design review procedures. These issues indicate a lack of adequate controls for ensuring product quality and regulatory compliance.

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/dana-medical-co-ltd/976534b3-2677-49a7-9ded-e03521674fc8

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