FDA Inspection 914952 — Michael Dalsing, MD
The FDA completed an inspection of Michael Dalsing, MD on Feb 18, 2015 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |