FDA Inspection 652486 — Ann E Woolfrey MD
The FDA completed an inspection of Ann E Woolfrey MD on March 15, 2010 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2975 | 21 CFR 812.110(c) | Investigator did not supervise use of investigational device |