750971

Banco de Sangre de Servicios Mutuos, Inc. — FEI 2677485

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 19, 2011
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
San Juan, PR (United States)

Citations

IDCFRDescription
10621 CFR 606.120(a)Separation of labeling operations
15421 CFR 606.160(a)(1)Concurrent documentation
15721 CFR 606.160(d)Retention period
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
907721 CFR 600.12(a)Maintenance - completeness
9821 CFR 606.100(c)Thorough investigations