FDA Inspection 886230 — Bloodworks
The FDA completed an inspection of Bloodworks on Jul 3, 2014 in Renton, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 3, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- 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 |