FDA Inspection 1066784 — We Are Blood
The FDA completed an inspection of We Are Blood on Sep 20, 2018 in Austin, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 20, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 9097 | 21 CFR 600.15 | Blood & Blood Components |