FDA Inspection 696355 — Ruben A. Quintero M.D.
The FDA completed an inspection of Ruben A. Quintero M.D. on Nov 5, 2010 in Coral Gables, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Coral Gables, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |