710462

Gulf Coast Regional Blood Center — FEI 3002133806

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 9, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Houston, TX (United States)

Citations

IDCFRDescription
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations