848340

Advanced Reproductive Health Centers LTD, Chicago IVF — FEI 3010384676

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Valparaiso, IN (United States)

Citations

IDCFRDescription
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1228621 CFR 1271.80(b)Specimen collections not timely
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled
1229021 CFR 1271.80(d)(1)Reactive tests--not determined ineligible