1119798

Genesiscare — FEI 3007009870

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 25, 2020
Fiscal Year
2020
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Naples, FL (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs