FDA Inspection 563753 — Gerardo Gomez, MD
The FDA completed an inspection of Gerardo Gomez, MD on Feb 25, 2009 in Indianapolis, IN. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 25, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |