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ALCOHOLERA DE ZAPOPAN S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3008872564 • Zapopan, Jalisco • MEXICO

FEI

FEI Number

3008872564

📍

Location

Zapopan, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Calle Vicente Guerrero No. 295, Rancheria Agua Blanca Poblado, Zapopan, Zapopan, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

34.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/3/2023
Latest Refusal
7/3/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
48.9×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
7/3/2023
62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is ALCOHOLERA DE ZAPOPAN S.A. DE C.V.'s FDA import refusal history?

ALCOHOLERA DE ZAPOPAN S.A. DE C.V. (FEI: 3008872564) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2023 to 7/3/2023.

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. ALCOHOLERA DE ZAPOPAN S.A. DE C.V.'s FEI number is 3008872564.

What types of violations has ALCOHOLERA DE ZAPOPAN S.A. DE C.V. received?

ALCOHOLERA DE ZAPOPAN S.A. DE C.V. 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 ALCOHOLERA DE ZAPOPAN S.A. DE C.V. come from?

All FDA import refusal data for ALCOHOLERA DE ZAPOPAN S.A. DE C.V. 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.