FDA Inspection 1066670 — Stearns Packaging Corporation

Stearns Packaging Corporation — FEI 3000209986

The FDA completed an inspection of Stearns Packaging Corporation on September 24, 2018 in Madison, WI. 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
September 24, 2018
Fiscal Year
2018
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Madison, WI (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
121521 CFR 211.67(b)Written procedures not established/followed
191221 CFR 211.166(a)Written program not followed
360321 CFR 211.160(b)Scientifically sound laboratory controls