833540

LifeStream Blood Bank — FEI 2074143

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 14, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
San Bernardino, CA (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7821 CFR 606.100(c)Record review prior to release
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations