Company
United StatesAvinger Inc., Redwood City, CA – FDA Inspections
Inspection records and compliance data for Avinger Inc. in Redwood City, California. 4 FDA inspections on record, last inspected January 25, 2017.
Company Profile
This profile covers Avinger Inc. based in Redwood City, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 11, 2009. Last inspected January 25, 2017.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 25, 2017 | Not classified | Medical Devices & Rad Health | 1004711 |
| May 24, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 833423 |
| February 2, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 707168 |
| June 11, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 588853 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Avinger Inc.
FEI Number
3007498664
Address
400 Chesapeake Dr, Redwood City, California 94063, United States
Country
United States
ID: fbe4fce2-ff2a-4a39-aa77-861f5b15e4f6