FDA Inspection 1247858 — Blair M. Brengle, M.D.
The FDA completed an inspection of Blair M. Brengle, M.D. on August 29, 2024 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 22728 | 21 CFR 312.64(b) | Safety Reports - Non-Serious Events |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |