FDA Inspection 1287050 — Michael T. Somenek, M.D.
The FDA completed an inspection of Michael T. Somenek, M.D. on Oct 10, 2025 in Washington, DC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 10, 2025
- Fiscal Year
- 2026
- 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 |