FDA Inspection 981344 — We Are Blood
The FDA completed an inspection of We Are Blood on Jul 27, 2016 in Austin, TX. 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)
- End Date
- Jul 27, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |