FDA Inspection
Richard E. Ringel, M.D.Richard E. Ringel, M.D. – FDA Inspection, Feb 3, 2009
Record Details
This FDA Inspection record concerns Richard E. Ringel, M.D., with an inspection on February 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Richard E. Ringel, M.D.
- Inspection Date
- February 3, 2009
- Product Type
- Devices
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ID · 80947c8c-1b1d-4ab8-a5f2-30514c928d05
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 557980
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.43(c)(4)(i)No investigation agreement statement of commitment
- 21 CFR 812.43(c)(4)(iii)No informed consent statement in investigator agreement
- 21 CFR 812.43(c)(4)(ii)No supervision commitment in investigator agreement
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.150(b)(4)No 6-month sponsor reports of current investigators
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.43(b)Sponsor shipped devices to unqualified person(s)
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Other FDA inspections of Richard E. Ringel, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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