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Manzela USA, LLC, Mcallen, TX – FDA Inspections

Inspection records and compliance data for Manzela USA, LLC in Mcallen, Texas. 5 FDA inspections on record (1 OAI), 3 Form 483s, 1 warning letter, last inspected September 09, 2025.

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Company Profile

This profile covers Manzela USA, LLC based in Mcallen, Texas, United States.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
4
NAI
0
Form 483s
3
Warning letters
1

First inspected May 13, 2020. Last inspected September 9, 2025.

Most cited issue areas

  • Develop FSVP2 inspections
  • Verification activity before import, periodically2 inspections
  • Approved supplier procedures - importer established1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
September 9, 2025VAIFoods & Cosmetics · Foodborne Biological Hazards1280946
January 16, 2025VAIFoods & Cosmetics · Foodborne Biological Hazards1258325
May 18, 2023VAIFoods & Cosmetics · Foodborne Biological Hazards1205566
June 24, 2022OAIFoods & Cosmetics · Foodborne Biological Hazards1172684
May 13, 2020VAIFoods & Cosmetics · Foodborne Biological Hazards1123722
FDA documents

Warning Letters (1)

  • Warning Letters · June 24, 2022
People (2)
Todd W. Cato
Person
Emmanuel Dominguez
Person
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Company Information

Name

Manzela USA, LLC

FEI Number

3014477606

Address

1300 E Hackberry Ave Ste B, Mcallen, Texas 78501, United States

Country

United States

ID: e3060e8d-91dc-4989-9980-f9bb8ac10885

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