FDA Inspection
Melaleuca IncMelaleuca Inc – FDA Inspection, Nov 2, 2011
Record Details
This FDA Inspection record concerns Melaleuca Inc, with an inspection on November 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Melaleuca Inc
- Inspection Date
- November 2, 2011
- Product Type
- Drugs
View Company Profile
ID · 1da5eb14-2d78-450f-b0db-84e970ecbc65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 756483
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.198(b)(1)Complaint Record required information
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(c)Approve or reject procedures or specs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Melaleuca Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2025 | VAI | Seattle District Office | Drug Quality Assurance |
| August 9, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 8, 2013 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| November 3, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Melaleuca Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.