FDA Inspection 1205217 — James A. Simon, MD
The FDA completed an inspection of James A. Simon, MD on May 5, 2023 in Washington, DC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7012 | 21 CFR 812.100 | Investigator lack of control of investigational devices |