FDA Inspection 830314 — Bloodworks Northwest
The FDA completed an inspection of Bloodworks Northwest on April 23, 2013 in Eugene, 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
- April 23, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Eugene, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9243 | 21 CFR 630.40(a) | Notification |