FDA Inspection
Averion International, Inc.Averion International, Inc. – FDA Inspection, Oct 28, 2009
Record Details
This FDA Inspection record concerns Averion International, Inc., with an inspection on October 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Averion International, Inc.
- Inspection Date
- October 28, 2009
- Product Type
- Devices
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ID · 7b5ff6af-d0a5-4e80-af55-b38fd78fa08a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 624125
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
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Other FDA inspections of Averion International, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2008 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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