ImportRefusal LogoImportRefusal

SERVIER LABORATORY MEXICO SA DE

⚠️ High Risk

FEI: 3027404936 • Mexico City • MEXICO

FEI

FEI Number

3027404936

📍

Location

Mexico City

🇲🇽

Country

MEXICO
🏢

Address

Av Paseo De Las Palmas, , Mexico City, , Mexico

High Risk

FDA Import Risk Assessment

58.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/23/2025
Latest Refusal
7/14/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
79.6×20%
Frequency
9.1×10%
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

752×

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
62ODA03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/14/2023
62ODY03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SERVIER LABORATORY MEXICO SA DE's FDA import refusal history?

SERVIER LABORATORY MEXICO SA DE (FEI: 3027404936) has 2 FDA import refusal record(s) in our database, spanning from 7/14/2023 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. SERVIER LABORATORY MEXICO SA DE's FEI number is 3027404936.

What types of violations has SERVIER LABORATORY MEXICO SA DE received?

SERVIER LABORATORY MEXICO SA DE 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 SERVIER LABORATORY MEXICO SA DE come from?

All FDA import refusal data for SERVIER LABORATORY MEXICO SA DE 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.