1210547
MD Tox Laboratory — FEI 3011213917
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12342 | 21 CFR 1271.190(a) | Size, construction, location--prevent mix-ups etc. |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |
| 15019 | 21 CFR 1271.160(d) | Computer software verification |