735615

United-Guardian, Inc. — FEI 2410853

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 22, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hauppauge, NY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls