FDA Inspection 756853 — Jenis, Louis G., M.D.
The FDA completed an inspection of Jenis, Louis G., M.D. on December 7, 2011 in Newton, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 7, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Newton, MA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2969 | 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare |