FDA Inspection 821800 — American Red Cross Blood Services
The FDA completed an inspection of American Red Cross Blood Services on March 28, 2013 in Farmington, CT. 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
- March 28, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Farmington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |