972997

Morgan Gallacher — FEI 2022194

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 12, 2016
Fiscal Year
2016
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Santa Fe Springs, CA (United States)

Citations

IDCFRDescription
154021 CFR 211.125(a)Strict control not exercised over labeling issued
181021 CFR 211.160(a)Lab controls established, including changes
183321 CFR 211.84(d)(1)Identity Testing of Each Component
200821 CFR 211.186(a)Written procedures followed
202621 CFR 211.192Quality control unit review of records
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls