FDA Inspection
Advanced Image Enhancement, Inc.Advanced Image Enhancement, Inc. – FDA Inspection, Feb 1, 2011
Record Details
This FDA Inspection record concerns Advanced Image Enhancement, Inc., with an inspection on February 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 1, 2011
- Product Type
- Devices
View Company Profile
ID · 68294cc3-c735-411a-8896-949c0aeb8d62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 706763
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| March 26, 2010 | 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 654085 - 2010-03-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.