FDA Inspection 754004 — Bighorn Botanicals Inc

Bighorn Botanicals Inc — FEI 1000455965

The FDA completed an inspection of Bighorn Botanicals Inc on November 10, 2011 in Noxon, MT. 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: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2011
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Noxon, MT (United States)

Citations

IDCFRDescription
1553221 CFR 111.255(b)Batch record - complete
1574521 CFR 111.210(h)(1)Instructions; specifications; packaged, labeled
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1592721 CFR 111.103Written procedures - quality control operations