FDA Inspection
ITC Nexus DxITC Nexus Dx – FDA Inspection, Jan 7, 2009
Record Details
This FDA Inspection record concerns ITC Nexus Dx, with an inspection on January 7, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ITC Nexus Dx
- Inspection Date
- January 7, 2009
- Product Type
- Devices
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ID · 367309c9-faf8-4a71-b435-0f098a83ff0d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 556414
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
35- 21 CFR 820.72(b)(1)Calibration standard traceability
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(b)Documentation
Showing 10 of 35 citations.
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Other FDA inspections of ITC Nexus Dx
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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