FDA Inspection
Sense Technology IncSense Technology Inc – FDA Inspection, Nov 6, 2017
Record Details
This FDA Inspection record concerns Sense Technology Inc, with an inspection on November 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 80c882ef-bc8a-428b-b420-b27d36c9877b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030739
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(e)Documentation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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Other FDA inspections of Sense Technology Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 28, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sense Technology Inc
- FDA Inspection 834226 - 2013-06-03
- FDA Inspection 717400 - 2011-03-28
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