FDA Inspection
Melaleuca IncMelaleuca Inc – FDA Inspection, Aug 27, 2025
Record Details
This FDA Inspection record concerns Melaleuca Inc, with an inspection on August 27, 2025, issued by the Seattle District Office, covering human drugs.
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ID · d006c27a-e4c7-4873-b131-fa21d45da29f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1278564
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Melaleuca Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 3, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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