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HECHO EN MEXICO POR ULTRA LABORA

⚠️ High Risk

FEI: 3021179789 • Jalisco • MEXICO

FEI

FEI Number

3021179789

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

No 2920 Col Jamo Indust, , Jalisco, , Mexico

High Risk

FDA Import Risk Assessment

63.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
12/19/2025
Latest Refusal
12/19/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
98.7×20%
Frequency
20.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/19/2025
62GDJ42INDOMETHACIN (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/19/2025
61MDE51PREGABALIN (ANTI-CONVULSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HECHO EN MEXICO POR ULTRA LABORA's FDA import refusal history?

HECHO EN MEXICO POR ULTRA LABORA (FEI: 3021179789) has 2 FDA import refusal record(s) in our database, spanning from 12/19/2025 to 12/19/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. HECHO EN MEXICO POR ULTRA LABORA's FEI number is 3021179789.

What types of violations has HECHO EN MEXICO POR ULTRA LABORA received?

HECHO EN MEXICO POR ULTRA LABORA has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about HECHO EN MEXICO POR ULTRA LABORA come from?

All FDA import refusal data for HECHO EN MEXICO POR ULTRA LABORA is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.