Company
United StatesVertebral Technologies, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Vertebral Technologies, Inc. in Santa Clara, California. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected November 16, 2016.
Company Profile
This profile covers Vertebral Technologies, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 1
First inspected June 12, 2009. Last inspected November 16, 2016.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Individual Report of Malfunction1 inspection
- Investigation of device failures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 16, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 994689 |
| February 2, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 912320 |
| April 16, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 776625 |
| June 12, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 588231 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Vertebral Technologies, Inc.
FEI Number
3007617183
Address
2344 Walsh Ave, Santa Clara, California 95051, United States
Country
United States
ID: 136ed3a9-e2ed-492a-9c70-30d12953740f