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JG Atlas Comercios, SA de CV

⚠️ Moderate Risk

FEI: 3016829724 • Zapopan, Jalisco • MEXICO

FEI

FEI Number

3016829724

📍

Location

Zapopan, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Calle Trueno Paraisos Delcolli 871, Col. Paraisos Del Colli, Zapopan, Zapopan, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

47.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
4/7/2021
Latest Refusal
4/7/2021
Earliest Refusal

Score Breakdown

Violation Severity
86.4×40%
Refusal Volume
25.9×30%
Recency
4.8×20%
Frequency
40.0×10%
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

274×

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).

2924×

SUBSTITUTE

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

753×

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
4/7/2021
62HDK05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
292SUBSTITUTE
75UNAPPROVED
Division of Southwest Imports (DSWI)
4/7/2021
62HDK05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
292SUBSTITUTE
75UNAPPROVED
Division of Southwest Imports (DSWI)
4/7/2021
62HDK05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
292SUBSTITUTE
75UNAPPROVED
Division of Southwest Imports (DSWI)
4/7/2021
62HDK05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
292SUBSTITUTE
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is JG Atlas Comercios, SA de CV's FDA import refusal history?

JG Atlas Comercios, SA de CV (FEI: 3016829724) has 4 FDA import refusal record(s) in our database, spanning from 4/7/2021 to 4/7/2021.

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. JG Atlas Comercios, SA de CV's FEI number is 3016829724.

What types of violations has JG Atlas Comercios, SA de CV received?

JG Atlas Comercios, 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 JG Atlas Comercios, SA de CV come from?

All FDA import refusal data for JG Atlas Comercios, 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.