# FDA 483 - Yukon Medical, LLC - April 06, 2018

Source: https://www.globalkeysolutions.net/records/483/yukon-medical-llc/2ab03167-35e6-497c-ab89-749eddc65568

> FDA 483 for Yukon Medical, LLC on April 06, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yukon Medical, LLC
- Inspection Date: 2018-04-06
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Yukon Medical, LLC in Durham, NC, revealed significant deficiencies in their medical device design control processes. The firm failed to adequately document design input requirements, establish procedures for design validation, and ensure proper design transfer into production specifications for their AT-ADAPT, 20mm VVAD device. These observations indicate a need for improved quality system procedures in device development.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/yukon-medical-llc/b159b552-d9ec-4cb6-989e-dfcb5f43b16b

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7