FDA Inspection 557980 — Richard E. Ringel, M.D.
The FDA completed an inspection of Richard E. Ringel, M.D. on Feb 3, 2009 in Baltimore, MD. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Baltimore, MD (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2935 | 21 CFR 812.43(b) | Sponsor shipped devices to unqualified person(s) |
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 2941 | 21 CFR 812.43(c)(4)(ii) | No supervision commitment in investigator agreement |
| 2942 | 21 CFR 812.43(c)(4)(iii) | No informed consent statement in investigator agreement |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3046 | 21 CFR 812.150(b)(4) | No 6-month sponsor reports of current investigators |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |