FDA Inspection 1111300 — Robert M. Pascuzzi, M.D.
The FDA completed an inspection of Robert M. Pascuzzi, M.D. on November 22, 2019 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7517 | 21 CFR 312.66 | Initial and continuing review |