FDA Inspection
Innerspace Neuro Solutions, IncInnerspace Neuro Solutions, Inc – FDA Inspection, Jun 30, 2010
Record Details
This FDA Inspection record concerns Innerspace Neuro Solutions, Inc, with an inspection on June 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 30, 2010
- Product Type
- Devices
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ID · 48e7b543-c212-4fe0-bee3-791f9e301b90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671662
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Innerspace Neuro Solutions, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2017 | Not classified | Los Angeles District Office |
Other documents for Innerspace Neuro Solutions, Inc
- FDA Inspection 1019769 - 2017-06-20
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