FDA Inspection 842314 — Sandeep Bagla, MD
The FDA completed an inspection of Sandeep Bagla, MD on July 31, 2013 in Mc Lean, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Mc Lean, VA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2923 | 21 CFR 812.20(a)(1) | Did not submit IDE application to FDA |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2973 | 21 CFR 812.110(a) | Subject participation prior to study approval |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |
| 3027 | 21 CFR 812.150(a)(4) | Investigator non-emergency safety or soundness changes |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |