FDA Inspection 611783 — The American National Red Cross
The FDA completed an inspection of The American National Red Cross on August 27, 2009 in Wichita, KS. 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
- August 27, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |