FDA Inspection 896923 — TCI Biotech, USA LLC

TCI Biotech, USA LLC — FEI 3003969912

The FDA completed an inspection of TCI Biotech, USA LLC on September 24, 2014 in American Fork, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 24, 2014
Fiscal Year
2014
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
American Fork, UT (United States)

Citations

IDCFRDescription
1273421 CFR 120.12(a)Records required - not maintained
994721 CFR 120.11(b)HACCP plan - not validated