FDA Inspection 1247461 — Alexander Khoruts, M.D., Sponsor-Investigator
The FDA completed an inspection of Alexander Khoruts, M.D., Sponsor-Investigator on Aug 26, 2024 in Minneapolis, MN. 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
- Aug 26, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7409 | 21 CFR 312.53(b) | Shipment to unauthorized persons |
| 7629 | 21 CFR 312.56(c) | Annual report |