FDA Inspection
Michael E. Ring, MDMichael E. Ring, MD – FDA Inspection, Aug 23, 2012
Record Details
This FDA Inspection record concerns Michael E. Ring, MD, with an inspection on August 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Michael E. Ring, MD
- Inspection Date
- August 23, 2012
- Product Type
- Devices
View Company Profile
ID · 2e2f9574-d380-46b2-babd-4f9c0f24ef4c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 792208
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.150(a)(4)No approval for investigator change in non-emergency
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 812.150(a)(4)Investigator report of emergency use
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Michael E. Ring, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Michael E. Ring, MD
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.