FDA Inspection 596066 — Oregon Health & Science University
The FDA completed an inspection of Oregon Health & Science University on Jul 2, 2009 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 2, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |