FDA Inspection 790518 — Bloodworks
The FDA completed an inspection of Bloodworks on Jul 6, 2012 in Renton, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Renton, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |