FDA Inspection 1064062 — Threshold Enterprises, Ltd.

Threshold Enterprises, Ltd. — FEI 2918667

The FDA completed an inspection of Threshold Enterprises, Ltd. on Aug 27, 2018 in Scotts Valley, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 27, 2018
Fiscal Year
2018
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Scotts Valley, CA (United States)

Citations

IDCFRDescription
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1584021 CFR 111.70(e)Specifications - contamination limits
1593821 CFR 111.105(f)Quality control - representative samples
1594421 CFR 111.105(i)QC - required operations master manufacturing/batch records

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.