FDA Inspection
Avinger Inc.Avinger Inc. – FDA Inspection, Feb 2, 2011
Record Details
This FDA Inspection record concerns Avinger Inc., with an inspection on February 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avinger Inc.
- Inspection Date
- February 2, 2011
- Product Type
- Devices
View Company Profile
ID · ec69dc9a-6132-4757-a6bd-2ca0a8dc4bb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707168
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Avinger Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2017 | Not classified | San Francisco District Office | |
| May 24, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 11, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Avinger Inc.
- FDA Inspection 1004711 - 2017-01-25
- FDA Inspection 833423 - 2013-05-24
- FDA Inspection 588853 - 2009-06-11
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