FDA Inspection 1150171 — Michael D. Leise, M.D., Clinical Investigator
The FDA completed an inspection of Michael D. Leise, M.D., Clinical Investigator on August 27, 2021 in Rochester, MN. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Rochester, MN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |