666986
American Red Cross Blood Services — FEI 1273014
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 15, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Farmington, CT (United States)
Citations
| ID | CFR | Description |
| 10005 | n/a | Procedural requirements |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |