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FARMACIA GUADALAJARA SA DE CV

⚠️ Moderate Risk

FEI: 3013603430 • Guadalajara • MEXICO

FEI

FEI Number

3013603430

📍

Location

Guadalajara

🇲🇽

Country

MEXICO
🏢

Address

Av Enrique Diaz de Leon, , Guadalajara, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/26/2019
Latest Refusal
6/26/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
6/26/2019
62MDO08MENTHOL (ANTI-PRURITIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FARMACIA GUADALAJARA SA DE CV's FDA import refusal history?

FARMACIA GUADALAJARA SA DE CV (FEI: 3013603430) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2019 to 6/26/2019.

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. FARMACIA GUADALAJARA SA DE CV's FEI number is 3013603430.

What types of violations has FARMACIA GUADALAJARA SA DE CV received?

FARMACIA GUADALAJARA 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 FARMACIA GUADALAJARA SA DE CV come from?

All FDA import refusal data for FARMACIA GUADALAJARA 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.