FDA Inspection
Melaleuca IncMelaleuca Inc – FDA Inspection, Nov 3, 2010
Record Details
This FDA Inspection record concerns Melaleuca Inc, with an inspection on November 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Melaleuca Inc
- Inspection Date
- November 3, 2010
- Product Type
- Drugs
View Company Profile
ID · 22e8e48c-c323-4d44-a94c-f71b2828a1f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696481
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.42(c)(8)Released Drug Products Area
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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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 |
| 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 |
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