FDA Inspection 752473 — American Red Cross Blood Services
The FDA completed an inspection of American Red Cross Blood Services on November 1, 2011 in Omaha, NE. 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
- November 1, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 78 | 21 CFR 606.100(c) | Record review prior to release |