FDA Inspection 665947 — Oregon Health & Science University
The FDA completed an inspection of Oregon Health & Science University on June 9, 2010 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
- June 9, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |