FDA Inspection
ITC Nexus DxITC Nexus Dx – FDA Inspection, Nov 12, 2010
Record Details
This FDA Inspection record concerns ITC Nexus Dx, with an inspection on November 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ITC Nexus Dx
- Inspection Date
- November 12, 2010
- Product Type
- Devices
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ID · d32aa5b0-f2f3-4c8d-8b62-aeef0f6be06b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695252
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
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Other FDA inspections of ITC Nexus Dx
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 7, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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