FDA Inspection 798415 — Solta Medical Inc
The FDA completed an inspection of Solta Medical Inc on August 17, 2012 in Pleasanton, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 17, 2012
- Fiscal Year
- 2012
- 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 |
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |
| 2952 | 21 CFR 812.46(b)(1) | No evaluation of unanticipated adverse effects |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |
| 3002 | 21 CFR 812.140(b)(5) | Sponsor records of adverse device effects & complaints |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |
| 7384 | 21 CFR 50.25(b)(1) | Statement of risks |