968939

Oximeter Plus, Inc — FEI 3007176465

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 25, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Roslyn Heights, NY (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures