FDA Inspection 804766 — Providence St. Vincent Medical Center
The FDA completed an inspection of Providence St. Vincent Medical Center on October 25, 2012 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |