FDA Inspection 831757 — Rolando Garcia, Jr., MD
The FDA completed an inspection of Rolando Garcia, Jr., MD on May 10, 2013 in Aventura, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Aventura, FL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |