FDA Inspection
Manzela USA, LLCManzela USA, LLC – FDA Inspection, Jun 24, 2022
Record Details
This FDA Inspection record concerns Manzela USA, LLC, with an inspection on June 24, 2022, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Manzela USA, LLC
- Inspection Date
- June 24, 2022
- Product Type
- Food/cosmetics
View Company Profile
ID · fbb405e2-6181-4e41-a891-00d2b23cad55
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1172684
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 1.506(e)(1)Verification activity before import, periodically
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.505(c)(2)Reevaluate - 3 years
- 21 CFR 1.506(d)(1)(i)Verification activity assurance
- 21 CFR 1.506(b)Supplier verification - establish written procedures
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Manzela USA, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2025 | VAI | Dallas District Office | Foodborne Biological Hazards |
| January 16, 2025 | VAI | Dallas District Office | Foodborne Biological Hazards |
| May 18, 2023 | VAI | 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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