FDA Inspection 564021 — Lane, Stephen S, MD Clinical Investigator
The FDA completed an inspection of Lane, Stephen S, MD Clinical Investigator on Feb 26, 2009 in Stillwater, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Stillwater, MN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |