FDA Inspection
Neuromechanical Innovations, LLCNeuromechanical Innovations, LLC – FDA Inspection, Dec 13, 2023
Record Details
This FDA Inspection record concerns Neuromechanical Innovations, LLC, with an inspection on December 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 946ecd0f-d421-4e7b-a442-ce0488c31cb5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1225102
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Neuromechanical Innovations, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neuromechanical Innovations, LLC
- FDA Inspection 1056263 - 2018-06-14
- FDA Inspection 838835 - 2013-06-14
- FDA Inspection 726213 - 2011-05-12
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