FDA Inspection 1112329 — Michael Steinmetz, M.D.
The FDA completed an inspection of Michael Steinmetz, M.D. on December 11, 2019 in Cleveland, OH. 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
- December 11, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Cleveland, OH (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 3025 | 21 CFR 812.150(a)(3) | No investigator progress reports |