FDA Inspection
Noraxon USA, Inc.Noraxon USA, Inc. – FDA Inspection, Sep 11, 2018
Record Details
This FDA Inspection record concerns Noraxon USA, Inc., with an inspection on September 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5835c144-cd22-4d1c-bcd5-f2068c7e974b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1065807
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Noraxon USA, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 30, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 27, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Noraxon USA, Inc.
- FDA Inspection 1224841 - 2023-11-30
- FDA Inspection 884760 - 2014-06-24
- FDA Inspection 751301 - 2011-10-27
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