584441

CBR Systems Inc — FEI 3003374183

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Tucson, AZ (United States)

Citations

IDCFRDescription
1227921 CFR 1271.75(b)Risk factors, leukocyte-rich cells or tissues
1236421 CFR 1271.195(c)Monitoring-microorganisms where appropriate
1238721 CFR 1271.220(a)Causing contamination, increasing risks
1239821 CFR 1271.230(a)Validation & approval--established procedures