FDA Inspection 778338 — Jeffery M. Adelglass, M.D.
The FDA completed an inspection of Jeffery M. Adelglass, M.D. on April 24, 2012 in Plano, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Plano, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2969 | 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |