FDA Inspection 791521 — Mark Hoyer, M.D.
The FDA completed an inspection of Mark Hoyer, M.D. on Jul 16, 2012 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |