FDA Inspection 667734 — Gordon, Stephen W. MD
The FDA completed an inspection of Gordon, Stephen W. MD on July 13, 2010 in Las Vegas, NV. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 13, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Las Vegas, NV (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 3023 | 21 CFR 812.150(a)(2) | Investigator report of IRB withdrawal of approval |