771123
Hemarus, LLC — FEI 3007786836
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 2, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3248 | 21 CFR 640.63(a) | Determining donor suitability |
| 335 | 21 CFR 640.65(b)(1)(i) | Serological test |
| 353 | 21 CFR 640.68(b) | Final container |
| 3543 | 21 CFR 610.46(a)(1) | Quarantine and notification |
| 3642 | 21 CFR 640.76(c) | Source Plasma - Re-labeling |
| 366 | 21 CFR 640.72(b) | Cross reference of donor record to unit of plasma |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 9314 | 21 CFR 640.65(b)(2)(i) | Physician review of results |
| 9317 | 21 CFR 640.65(b)(8) | Timing |
| 98 | 21 CFR 606.100(c) | Thorough investigations |