FDA Inspection 681402 — Bloodworks
The FDA completed an inspection of Bloodworks on Sep 22, 2010 in Seattle, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 22, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 212 | 21 CFR 640.3(b)(3) | Qualifications of donor - hemoglobin |
| 98 | 21 CFR 606.100(c) | Thorough investigations |