Company
United StatesNoraxon USA, Inc., Scottsdale, AZ – FDA Inspections
Inspection records and compliance data for Noraxon USA, Inc. in Scottsdale, Arizona. 4 FDA inspections on record, 2 Form 483s, last inspected November 30, 2023.
Company Profile
This profile covers Noraxon USA, Inc. based in Scottsdale, Arizona, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected October 27, 2011. Last inspected November 30, 2023.
Most cited issue areas
- Calibration procedures - content1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Training - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 30, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1224841 |
| September 11, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1065807 |
| June 24, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 884760 |
| October 27, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 751301 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Noraxon USA, Inc.
FEI Number
2084126
Address
15770 N Greenway Hayden Loop Ste 100, Scottsdale, Arizona 85260, United States
Country
United States
ID: a3c2a806-a940-4a37-920d-b9e31915e7ba