FDA Inspection
Neuronetrix Solutions, LLCNeuronetrix Solutions, LLC – FDA Inspection, Nov 7, 2022
Record Details
This FDA Inspection record concerns Neuronetrix Solutions, LLC, with an inspection on November 7, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neuronetrix Solutions, LLC
- Inspection Date
- November 7, 2022
- Product Type
- Devices
View Company Profile
ID · 435b9d49-013b-4622-ac43-f36237e48550
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190863
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 806.20(a)Records not kept
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neuronetrix Solutions, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | NAI | Cincinnati District Office | Postmarket Assurance: Medical Devices |
| July 15, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neuronetrix Solutions, LLC
- FDA Inspection 1254409 - 2024-11-07
- FDA Inspection 1147137 - 2021-07-15
- FDA Inspection 1062857 - 2018-07-17
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