FDA Inspection
PRODUCE EL AMANECER LLCPRODUCE EL AMANECER LLC – FDA Inspection, Feb 7, 2025
Record Details
This FDA Inspection record concerns PRODUCE EL AMANECER LLC, with an inspection on February 7, 2025, issued by the Dallas District Office, covering foods & cosmetics.
- Office
- Dallas District Office
- Person
- Gonzalo Castillo (Issuing Officer)
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ID · d2c4a2bb-dc51-4333-8510-bf8424094f5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259347
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 1.506(d)(1)(i)Verification activity frequency
- 21 CFR 1.506(d)(1)(i)Verification activity assurance
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(b)Supplier verification - establish written procedures
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.510(b)(1)Record - translate to English
- 21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
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Other FDA inspections of PRODUCE EL AMANECER LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2024 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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