FDA Inspection 1096443 — The American National Red Cross
The FDA completed an inspection of The American National Red Cross on June 27, 2019 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 274 | 21 CFR 640.34(c) | Liquid Plasma - storage requirements |