FDA Inspection 1109089 — Ufine Herbs, LLC

Ufine Herbs, LLC — FEI 3013295533

The FDA completed an inspection of Ufine Herbs, LLC on November 7, 2019 in Omaha, NE. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 7, 2019
Fiscal Year
2020
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Omaha, NE (United States)

Citations

IDCFRDescription
1553121 CFR 111.255(a)Batch record - every batch
1573221 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
1576221 CFR 111.205(a)Master manufacturing record - each batch
1582521 CFR 111.65Quality control - quality, dietary supplement
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1584321 CFR 111.70(g)Specifications - finished packaging, labeling
1816121 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls