1031777

ABS Corporation — FEI 1950042

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 16, 2017
Fiscal Year
2018
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Omaha, NE (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
202421 CFR 211.188(b)(12)Documentation of Batch Investigations