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

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1222321 CFR 1271.47(b)Review and approval of procedures
1223621 CFR 1271.55(a)(2)Eligibility statement--basis of determination
1225021 CFR 1271.55(d)(4)Ten year retention
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV