FDA Inspection 746372 — American Red Cross Blood Services
The FDA completed an inspection of American Red Cross Blood Services on Sep 23, 2011 in Birmingham, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |