FDA Inspection 680222 — American National Red Cross (The)
The FDA completed an inspection of American National Red Cross (The) on September 13, 2010 in San Jose, CA. 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
- September 13, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |