748534
LifeSouth Community Blood Centers, Inc — FEI 3003707120
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 4, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3230 | 21 CFR 820.70(i) | Validation of changes to automated process software |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3452 | 21 CFR 601.12(b) | Major changes to an approved application |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |