FDA Inspection 1258135 — Jose D. Gutierrez, MD, MPH
The FDA completed an inspection of Jose D. Gutierrez, MD, MPH on Jan 10, 2025 in New York, NY. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 10, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22727 | 21 CFR 312.64(b) | Safety Reports - Serious Events |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7629 | 21 CFR 312.56(c) | Annual report |