1021791

Vapco Incorporated — FEI 1219408

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2017
Fiscal Year
2017
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Lawrence, MA (United States)

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
122721 CFR 211.67(c)Cleaning/maintenance records not kept
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
144821 CFR 211.111Establishment of time limitations
145021 CFR 211.113(a)Procedures for non-sterile drug products
183321 CFR 211.84(d)(1)Identity Testing of Each Component
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
201121 CFR 211.188(a)Accurate reproduction
355321 CFR 211.48(a)Plumbing System Defects
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358121 CFR 211.101(d)Verification of component addition
900121 CFR 211.22(a)Lack of quality control unit