FDA Inspection 622417 — Legacy Emanuel Medical Center
The FDA completed an inspection of Legacy Emanuel Medical Center on October 22, 2009 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 9225 | 21 CFR 606.171 | Biological product deviation report |