FDA Inspection
Ives EEG Solutions, LLCIves EEG Solutions, LLC – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Ives EEG Solutions, LLC, with an inspection on March 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b0a63b36-ed8a-4ef4-8b26-707f902dd168
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004457
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40(b)Document change records, maintained.
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Other FDA inspections of Ives EEG Solutions, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 8, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ives EEG Solutions, LLC
- FDA Inspection 1302196 - 2026-02-06
- FDA Inspection 1179579 - 2022-09-08
- FDA Inspection 806769 - 2012-10-12
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