FDA Inspection 1256432 — Julia C. Carnevale, M.D.
The FDA completed an inspection of Julia C. Carnevale, M.D. on Dec 12, 2024 in San Francisco, CA. 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). 13 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 22727 | 21 CFR 312.64(b) | Safety Reports - Serious Events |
| 22728 | 21 CFR 312.64(b) | Safety Reports - Non-Serious Events |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7230 | 21 CFR 50.27(b)(2) | Short form: Oral presentation/signing |
| 7380 | 21 CFR 50.27(b)(2) | Short form: IRB approval of oral presentation |
| 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 |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |