FDA Inspection 893202 — The American National Red Cross
The FDA completed an inspection of The American National Red Cross on August 15, 2014 in Maryland Heights, MO. 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 15, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Maryland Heights, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |