897638
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 30, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 155 | 21 CFR 606.160(b) | Required records |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 98 | 21 CFR 606.100(c) | Thorough investigations |