FDA Inspection 748534 — LifeSouth Community Blood Centers, Inc
The FDA completed an inspection of LifeSouth Community Blood Centers, Inc on Oct 4, 2011 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 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 |