FDA Inspection 696654 — Bloodworks
The FDA completed an inspection of Bloodworks on Oct 26, 2010 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 26, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Renton, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |