FDA Inspection
Manzela USA, LLCManzela USA, LLC – FDA Inspection, Jan 16, 2025
Record Details
This FDA Inspection record concerns Manzela USA, LLC, with an inspection on January 16, 2025, issued by the Dallas District Office, covering foods & cosmetics.
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ID · 144dc34f-8a3a-4578-b0a2-126b5e100358
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258325
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1.506(d)(2)Onsite audit
- 21 CFR 1.506(e)(1)Verification activity before import, periodically
- 21 CFR 1.505(b)Supplier approval - document
- 21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established
- 21 CFR 1.506(b)Supplier verification - follow written procedures
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Other FDA inspections of Manzela USA, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2025 | VAI | Dallas District Office | Foodborne Biological Hazards |
| May 18, 2023 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 24, 2022 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 13, 2020 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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