985842
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Junction, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 18132 | 21 CFR 640.21(e) | Frequency of plateletpheresis |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 36 | 21 CFR 606.40 | Suitable size, construction, etc. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 84 | 21 CFR 606.100(b)(5) | Accurate measurement of quantity of blood |