FDA Inspection 1035495 — Bloodworks
The FDA completed an inspection of Bloodworks on December 20, 2017 in Vancouver, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18134 | 21 CFR 640.21(g) | Informed consent |