FDA Inspection 1237012 — Patrick S. Kamath, M.D., Clinical Investigator
The FDA completed an inspection of Patrick S. Kamath, M.D., Clinical Investigator on Apr 26, 2024 in Rochester, MN. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Rochester, MN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |