FDA Inspection 756483 — Melaleuca Inc

Melaleuca Inc — FEI 3021937

The FDA completed an inspection of Melaleuca Inc on November 2, 2011 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). 5 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 2, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Idaho Falls, ID (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
185121 CFR 211.84(e)Rejecting When Specifications Not Met
261821 CFR 211.198(b)(1)Complaint Record required information
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
441321 CFR 211.194(a)(8)Second person sign off