FDA Inspection
Iris DiagnosticsIris Diagnostics – FDA Inspection, Dec 16, 2015
Record Details
This FDA Inspection record concerns Iris Diagnostics, with an inspection on December 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Iris Diagnostics
- Inspection Date
- December 16, 2015
- Product Type
- Devices
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ID · 208eeaaa-e8bb-416d-a892-16f965812fea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951542
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Iris Diagnostics
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 16, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Iris Diagnostics
- FDA Inspection 863178 - 2014-01-16
- FDA Inspection 755008 - 2011-11-16
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