FDA Inspection 886230 — Bloodworks
The FDA completed an inspection of Bloodworks on July 3, 2014 in Renton, WA. 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
- July 3, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Renton, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |