748491

Human Biosciences, Inc. — FEI 3008770963

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 18, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Gaithersburg, MD (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
311321 CFR 820.70(g)Equipment design and installation
367121 CFR 820.25(a)Personnel
369621 CFR 820.100(b)Documentation
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation