FDA Inspection 1010158 — James C. Roberts, M.D.
The FDA completed an inspection of James C. Roberts, M.D. on April 7, 2017 in Toledo, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Toledo, OH (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |