FDA Inspection
Vertebral Technologies, Inc.Vertebral Technologies, Inc. – FDA Inspection, Feb 2, 2015
Record Details
This FDA Inspection record concerns Vertebral Technologies, Inc., with an inspection on February 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vertebral Technologies, Inc.
- Inspection Date
- February 2, 2015
- Product Type
- Devices
View Company Profile
ID · 4e21fed2-8b41-450a-a86d-b1876a004bad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 912320
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vertebral Technologies, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vertebral Technologies, Inc.
- FDA Inspection 994689 - 2016-11-16
- FDA Inspection 776625 - 2012-04-16
- FDA Inspection 588231 - 2009-06-12
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