FDA Inspection 1177854 — Mitchell E. Horwitz, M.D.
The FDA completed an inspection of Mitchell E. Horwitz, M.D. on August 19, 2022 in Durham, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Durham, NC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |