FDA Inspection
Nutrix International LLCNutrix International LLC – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns Nutrix International LLC, with an inspection on April 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c8f5d79a-d2b5-453f-98fd-2a0e7d9fd7c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086064
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Nutrix International LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2025 | OAI | Denver District Office | Drug Quality Assurance |
| October 31, 2023 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Nutrix International LLC
- FDA Inspection 1269746 - 2025-04-25
- FDA Inspection 1221796 - 2023-10-31
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