FDA Inspection 546890 — American National Red Cross
The FDA completed an inspection of American National Red Cross on December 10, 2008 in Pomona, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |