Company
United StatesYukon Medical, LLC, Durham, NC – FDA Inspections
Inspection records and compliance data for Yukon Medical, LLC in Durham, North Carolina. 2 FDA inspections on record, 1 Form 483, last inspected April 06, 2018.
Company Profile
This profile covers Yukon Medical, LLC based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 23, 2015. Last inspected April 6, 2018.
Most cited issue areas
- Design input - documentation1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1047462 |
| April 23, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 926101 |
FDA documents
Form 483s (1)
EIRs (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Yukon Medical, LLC
FEI Number
3009631669
Address
4021 Stirrup Creek Dr Ste 200, Durham, North Carolina 27703, United States
Country
United States
ID: b159b552-d9ec-4cb6-989e-dfcb5f43b16b