FDA Inspection 1135272 — Benjamin S. Gonzalez, MD
The FDA completed an inspection of Benjamin S. Gonzalez, MD on February 3, 2021 in Silver Spring, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 3, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Silver Spring, MD (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7527 | 21 CFR 312.62(a) | Unused drug disposition (investigator) |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |