1062807

GeneXtend, LLC — FEI 3013598802

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223021 CFR 1271.50(a)Responsible person to determine, document
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence