1070324
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 26, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Frisco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 18115 | 21 CFR 630.30(a)(2) | Donor health |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |