FDA Inspection
Cyberonics, Inc.Cyberonics, Inc. – FDA Inspection, Dec 11, 2012
Record Details
This FDA Inspection record concerns Cyberonics, Inc., with an inspection on December 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cyberonics, Inc.
- Inspection Date
- December 11, 2012
- Product Type
- Devices
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ID · db65e672-0d88-4527-8569-ca8e1834be83
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809945
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Cyberonics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cyberonics, Inc.
- FDA Inspection 891133 - 2014-08-22
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