FDA Inspection 954108 — Cooper Farms, Inc.

Cooper Farms, Inc. — FEI 1520332

The FDA completed an inspection of Cooper Farms, Inc. on November 18, 2015 in Fort Recovery, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 18, 2015
Fiscal Year
2016
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Fort Recovery, OH (United States)

Citations

IDCFRDescription
178221 CFR 225.42(b)(7)Daily reconciliation, Investigation/corrective action of actual vs theoretical
181121 CFR 225.58(b)(1)Three assays per year
182121 CFR 225.58(b)(1)First batch assay
209721 CFR 225.102(b)(4)Daily review of production records