FDA Inspection 676440 — Rangen, LLC

Rangen, LLC — FEI 3016448

The FDA completed an inspection of Rangen, LLC on July 9, 2010 in Buhl, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 9, 2010
Fiscal Year
2010
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Buhl, ID (United States)

Citations

IDCFRDescription
185021 CFR 225.58(d)Assay results out of specification
188021 CFR 225.58(e)Distribution discontinued and control procedures established
188221 CFR 225.58(e)Subsequent production