Company
United StatesNuVasive Inc, San Diego, CA – FDA Inspections
Inspection records and compliance data for NuVasive Inc in San Diego, California. 8 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected May 26, 2017.
Company Profile
This profile covers NuVasive Inc based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 2
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 1
First inspected December 2, 2008. Last inspected May 26, 2017.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- No informed consent statement in investigator agreement1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 26, 2017 | VAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 1011810 |
| November 19, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 904804 |
| February 5, 2014 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 865024 |
| November 2, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 805149 |
| February 10, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 768996 |
| June 17, 2011 | NAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 729198 |
| August 13, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 605962 |
| December 2, 2008 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 548750 |
FDA documents
Warning Letters (1)
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Company Information
Name
NuVasive Inc
FEI Number
3002980729
Address
7475 Lusk Blvd, San Diego, California 92121, United States
Country
United States
ID: b60df9db-c2cf-4c29-abf9-4ae91cbe363a