681411

Vitalant — FEI 2971457

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 21, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Las Vegas, NV (United States)

Citations

IDCFRDescription
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
8821 CFR 606.100(b)(9)Written methods for investigating adverse reactions