553351

Pacific Reproductive Center, Inc. — FEI 3005861788

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 4, 2008
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Irvine, CA (United States)

Citations

IDCFRDescription
1223021 CFR 1271.50(a)Responsible person to determine, document
1225221 CFR 1271.60(a)Completion of eligibility determination
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1249221 CFR 1271.85(a)Infection with communicable disease agents
1249421 CFR 1271.85(c)Reproductive cells or tissues