FDA Inspection 898399 — World Gen, LLC

World Gen, LLC — FEI 1314598

The FDA completed an inspection of World Gen, LLC on Sep 17, 2014 in Hamilton, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Sep 17, 2014
Fiscal Year
2014
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Hamilton, NY (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance