FDA Inspection 753212 — LifeSouth Community Blood Centers Inc
The FDA completed an inspection of LifeSouth Community Blood Centers Inc on November 14, 2011 in Madison, AL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 14, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Madison, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 163 | 21 CFR 606.165(b) | Distribution records - content |
| 236 | 21 CFR 640.5(e) | Testing - inspection |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 241 | 21 CFR 640.11(b) | General requirements - inspection |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 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 |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |