FDA Inspection 792208 — Michael E. Ring, MD
The FDA completed an inspection of Michael E. Ring, MD on August 23, 2012 in Spokane, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Spokane, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 3028 | 21 CFR 812.150(a)(4) | No approval for investigator change in non-emergency |
| 3029 | 21 CFR 812.150(a)(4) | Investigator report of emergency use |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |