FDA Inspection
Quartet Technology, Inc.Quartet Technology, Inc. – FDA Inspection, Feb 1, 2012
Record Details
This FDA Inspection record concerns Quartet Technology, Inc., with an inspection on February 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Quartet Technology, Inc.
- Inspection Date
- February 1, 2012
- Product Type
- Devices
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ID · 54917ed2-cb82-4003-9d2c-d0722c55632e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765859
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Quartet Technology, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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