773341
Advanced Reproductive Medicine - University of Colorado Hospital — FEI 3005070054
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |