FDA Inspection 727977 — Oregon Health & Science University
The FDA completed an inspection of Oregon Health & Science University on May 27, 2011 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 27, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |