1149731

UNIVAR SOLUTIONS USA INC. — FEI 3015781829

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 25, 2021
Fiscal Year
2021
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Cincinnati, OH (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
184921 CFR 211.84(d)(6)Objectionable microbiological contamination
188321 CFR 211.165(a)Testing and release for distribution
188521 CFR 211.165(b)Microbiological testing
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
203121 CFR 211.194(a)Complete test data included in records
360221 CFR 211.160(a)Deviations from laboratory control requirements
363321 CFR 211.170(b)(1)Reserve sample retention time
900121 CFR 211.22(a)Lack of quality control unit