FDA Inspection 666986 — American Red Cross Blood Services
The FDA completed an inspection of American Red Cross Blood Services on June 15, 2010 in Farmington, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
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 |