1112479
Active Medical — FEI 3012340348
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sandy, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |