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Laboratorios Servet Sa De Cv

⚠️ Moderate Risk

FEI: 3012164312 • Cuajimalpa • MEXICO

FEI

FEI Number

3012164312

📍

Location

Cuajimalpa

🇲🇽

Country

MEXICO
🏢

Address

Av Lopez Mateeos 68, , Cuajimalpa, , 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
4/1/2016
Latest Refusal
4/1/2016
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
4/1/2016
61JDA09FENOFIBRATE (ANTI-CHOLESTEREMIC)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Laboratorios Servet Sa De Cv's FDA import refusal history?

Laboratorios Servet Sa De Cv (FEI: 3012164312) has 1 FDA import refusal record(s) in our database, spanning from 4/1/2016 to 4/1/2016.

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. Laboratorios Servet Sa De Cv's FEI number is 3012164312.

What types of violations has Laboratorios Servet Sa De Cv received?

Laboratorios Servet 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 Laboratorios Servet Sa De Cv come from?

All FDA import refusal data for Laboratorios Servet 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.