FDA Inspection
QView Medical, Inc.QView Medical, Inc. – FDA Inspection, Jan 11, 2018
Record Details
This FDA Inspection record concerns QView Medical, Inc., with an inspection on January 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d8d645cf-7085-4bf2-917d-ef5ab6de228c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037460
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(j)Design history file
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of QView Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 30, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for QView Medical, Inc.
- FDA Inspection 1158478 - 2021-12-10
- FDA Inspection 971477 - 2016-03-30
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