FDA Inspection 659032 — Oregon Health & Science University
The FDA completed an inspection of Oregon Health & Science University on April 21, 2010 in Portland, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 21, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |