FDA Inspection 548750 — NuVasive Inc
The FDA completed an inspection of NuVasive Inc on December 2, 2008 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Diego, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2942 | 21 CFR 812.43(c)(4)(iii) | No informed consent statement in investigator agreement |