FDA Inspection 896930 — Culbertson, M.D., William W.
The FDA completed an inspection of Culbertson, M.D., William W. on Aug 22, 2014 in Miami, FL. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Miami, FL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3065 | 21 CFR 812.140(a)(5) | Additional investigator records FDA requires |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |