FDA Inspection 1203105 — Elijah W. Stommel, M.D.
The FDA completed an inspection of Elijah W. Stommel, M.D. on April 11, 2023 in Lebanon, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lebanon, NH (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7629 | 21 CFR 312.56(c) | Annual report |