FDA Inspection
Neo Imagery Technologies, Inc.Neo Imagery Technologies, Inc. – FDA Inspection, May 1, 2009
Record Details
This FDA Inspection record concerns Neo Imagery Technologies, Inc., with an inspection on May 1, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 1, 2009
- Product Type
- Devices
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ID · b227b1e1-897b-410f-9309-88d9ccd32543
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 579099
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Neo Imagery Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neo Imagery Technologies, Inc.
- FDA Inspection 894343 - 2014-08-27
- FDA Inspection 780774 - 2012-05-01
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