FDA Inspection 595507 — American National Red Cross, The
The FDA completed an inspection of American National Red Cross, The on June 4, 2009 in Los Angeles, 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
- June 4, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |