FDA Inspection
Yukon Medical, LLCYukon Medical, LLC – FDA Inspection, Apr 6, 2018
Record Details
This FDA Inspection record concerns Yukon Medical, LLC, with an inspection on April 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9fa8833-314b-4b06-90fc-d08ba9c05b87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047462
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Yukon Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Yukon Medical, LLC
- FDA Inspection 926101 - 2015-04-23
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