ImportRefusal LogoImportRefusal

ALFASIGMA LABORATORIES MEXICO SA

⚠️ High Risk

FEI: 3035955513 • Alvaro • MEXICO

FEI

FEI Number

3035955513

📍

Location

Alvaro

🇲🇽

Country

MEXICO
🏢

Address

Insurgentes Sur No 2475, , Alvaro, , Mexico

High Risk

FDA Import Risk Assessment

59.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/23/2025
Latest Refusal
9/23/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
93.9×20%
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

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
9/23/2025
62GDA99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ALFASIGMA LABORATORIES MEXICO SA's FDA import refusal history?

ALFASIGMA LABORATORIES MEXICO SA (FEI: 3035955513) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2025 to 9/23/2025.

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. ALFASIGMA LABORATORIES MEXICO SA's FEI number is 3035955513.

What types of violations has ALFASIGMA LABORATORIES MEXICO SA received?

ALFASIGMA LABORATORIES MEXICO SA 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 ALFASIGMA LABORATORIES MEXICO SA come from?

All FDA import refusal data for ALFASIGMA LABORATORIES MEXICO SA 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.