957296

Hoof Health, LLC — FEI 3011067227

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 7, 2016
Fiscal Year
2016
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Johnson Creek, WI (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
154021 CFR 211.125(a)Strict control not exercised over labeling issued
178721 CFR 211.80(a)Procedures To Be in Writing
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
900121 CFR 211.22(a)Lack of quality control unit