1280962

United-Guardian, Inc. — FEI 2410853

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 4, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hauppauge, NY (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
136121 CFR 211.100(a)Absence of Written Procedures
430421 CFR 211.68(b)Written record not kept of program and validation data
434221 CFR 211.142(b)Storage under appropriate conditions
439121 CFR 211.180(e)(2)Items to cover on annual reviews