783686
Genesis Biologics, Inc. — FEI 3008066433
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12407 | 21 CFR 1271.250(b) | Verification of label accuracy, legibility, integrity |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 12478 | 21 CFR 1271.370(b)(3) | Expiration date on label |