FDA Inspection 750418 — Bloodworks
The FDA completed an inspection of Bloodworks on October 21, 2011 in Lynnwood, WA. 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
- October 21, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lynnwood, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |