FDA Inspection 989601 — EarthLab Holdings Inc

EarthLab Holdings Inc — FEI 3001237894

The FDA completed an inspection of EarthLab Holdings Inc on September 30, 2016 in Creswell, OR. 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
September 30, 2016
Fiscal Year
2016
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Creswell, OR (United States)

Citations

IDCFRDescription
195721 CFR 211.180(e)(2)Review of problem drugs
262121 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
432321 CFR 211.115(a)Reprocessing procedures lack steps to be taken
439321 CFR 211.186(b)(2)Name, weight of active ingredient; total weight or measure