FDA Inspection 1023314 — Vale Enterprises, Incorporated

Vale Enterprises, Incorporated — FEI 3003387781

The FDA completed an inspection of Vale Enterprises, Incorporated on August 29, 2017 in Denver, CO. 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
August 29, 2017
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Denver, CO (United States)

Citations

IDCFRDescription
1580921 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
1592021 CFR 111.95(b)(1)Records - established specifications
1592121 CFR 111.95(b)(2)Documentation - supplier qualification
1604721 CFR 111.510Returned dietary supplement - material review, disposition