Company
United StatesCyberonics, Inc., Austin, TX – FDA Inspections
Inspection records and compliance data for Cyberonics, Inc. in Austin, Texas. 2 FDA inspections on record, last inspected August 22, 2014.
Company Profile
This profile covers Cyberonics, Inc. based in Austin, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 11, 2012. Last inspected August 22, 2014.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate procedures for storage.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 891133 |
| December 11, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 809945 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cyberonics, Inc.
FEI Number
3009390454
Address
1611 Headway Cir Ste 1A Ste 200, Austin, Texas 78754, United States
Country
United States
ID: e5fd47e2-b35d-433f-94b2-2665e71d8df2