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Grupo Asimex de Mexico SA de CV

⚠️ Moderate Risk

FEI: 3008944019 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3008944019

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Mario Pani No 750 Piso 10-C, Col. Santa Fe Cuajimalpa, Cuajimalpa De Morelos, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

39.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
3
Unique Violations
4/1/2021
Latest Refusal
4/1/2021
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

2921×

SUBSTITUTE

It appears to be a drug that a substance has been substituted wholly or in part.

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
4/1/2021
62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
292SUBSTITUTE
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Grupo Asimex de Mexico SA de CV's FDA import refusal history?

Grupo Asimex de Mexico SA de CV (FEI: 3008944019) has 1 FDA import refusal record(s) in our database, spanning from 4/1/2021 to 4/1/2021.

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. Grupo Asimex de Mexico SA de CV's FEI number is 3008944019.

What types of violations has Grupo Asimex de Mexico SA de CV received?

Grupo Asimex de Mexico SA de CV has been cited for 3 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 Grupo Asimex de Mexico SA de CV come from?

All FDA import refusal data for Grupo Asimex 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.