FDA Inspection 882308 — Solta Medical Inc
The FDA completed an inspection of Solta Medical Inc on June 17, 2014 in Pleasanton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Pleasanton, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 2941 | 21 CFR 812.43(c)(4)(ii) | No supervision commitment in investigator agreement |
| 2946 | 21 CFR 812.45 | Sponsor provide device information to investigators |
| 7665 | 21 CFR 50.20 | Exculpatory language, waiving of rights |