FDA Inspection
Advanced Image Enhancement, Inc.Advanced Image Enhancement, Inc. – FDA Inspection, Mar 26, 2010
Record Details
This FDA Inspection record concerns Advanced Image Enhancement, Inc., with an inspection on March 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 26, 2010
- Product Type
- Devices
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ID · 79c8c047-6cec-4bde-a335-215be6db241e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 654085
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Advanced Image Enhancement, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 1, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Image Enhancement, Inc.
- FDA Inspection 1236885 - 2024-03-20
- FDA Inspection 820903 - 2013-03-01
- FDA Inspection 706763 - 2011-02-01
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