FDA Inspection 1112992 — Patel, Vikas V.
The FDA completed an inspection of Patel, Vikas V. on Dec 17, 2019 in Aurora, CO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 17, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Aurora, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |