FDA Inspection 791239 — Oregon Health & Science University
The FDA completed an inspection of Oregon Health & Science University on Jul 25, 2012 in Portland, OR. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 25, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |