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EXPLORADORA DE MEXICO SA DE CV

⚠️ High Risk

FEI: 3016783174 • Nauclapan De Juarex • MEXICO

FEI

FEI Number

3016783174

📍

Location

Nauclapan De Juarex

🇲🇽

Country

MEXICO
🏢

Address

Calle 7 No 6 Fracc Whit, , Nauclapan De Juarex, , Mexico

High Risk

FDA Import Risk Assessment

50.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/13/2023
Latest Refusal
7/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
49.4×20%
Frequency
10.0×10%
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

751×

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
7/13/2023
66VCF99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is EXPLORADORA DE MEXICO SA DE CV's FDA import refusal history?

EXPLORADORA DE MEXICO SA DE CV (FEI: 3016783174) has 1 FDA import refusal record(s) in our database, spanning from 7/13/2023 to 7/13/2023.

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. EXPLORADORA DE MEXICO SA DE CV's FEI number is 3016783174.

What types of violations has EXPLORADORA DE MEXICO SA DE CV received?

EXPLORADORA DE MEXICO SA DE CV 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 EXPLORADORA DE MEXICO SA DE CV come from?

All FDA import refusal data for EXPLORADORA DE MEXICO SA DE CV 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.