FDA Inspection 806598 — Teoxane S.A.
The FDA completed an inspection of Teoxane S.A. on November 16, 2012 in Geneva. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Geneva (Switzerland)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |
| 3054 | 21 CFR 812.150(b)(7) | 30-day sponsor notification to FDA |