FDA Inspection 800739 — Susan H. Weinkle, M.D.
The FDA completed an inspection of Susan H. Weinkle, M.D. on September 21, 2012 in Bradenton, FL. 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
- September 21, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bradenton, FL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |