FDA Inspection
Melaleuca IncMelaleuca Inc – FDA Inspection, Aug 9, 2019
Record Details
This FDA Inspection record concerns Melaleuca Inc, with an inspection on August 9, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2f8e84a9-67a2-47c0-b5ee-37080fafb91e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099319
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Melaleuca Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2025 | VAI | Seattle District Office | 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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