FDA Inspection 577356 — James W. Baker, MD
The FDA completed an inspection of James W. Baker, MD on April 14, 2009 in Portland, OR. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Portland, OR (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |