FDA Inspection 545612 — The National American Red Cross
The FDA completed an inspection of The National American Red Cross on October 17, 2008 in Peoria, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Peoria, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |