FDA Inspection 1099319 — Melaleuca Inc

Melaleuca Inc — FEI 3021937

The FDA completed an inspection of Melaleuca Inc on August 9, 2019 in Idaho Falls, ID. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 9, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Idaho Falls, ID (United States)

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
361321 CFR 211.160(b)(4)Establishment of calibration procedures