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LABORATORIOS BEST SA

⚠️ High Risk

FEI: 3024309112 • Mexico City • MEXICO

FEI

FEI Number

3024309112

📍

Location

Mexico City

🇲🇽

Country

MEXICO
🏢

Address

Municipio Libre # 199 J, , Mexico City, , Mexico

High Risk

FDA Import Risk Assessment

57.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/4/2025
Latest Refusal
10/30/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
76.6×20%
Frequency
11.3×10%
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
8/4/2025
61NAA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/30/2023
60XCA02METOPROLOL (ANTI-ADRENERGIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS BEST SA's FDA import refusal history?

LABORATORIOS BEST SA (FEI: 3024309112) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2023 to 8/4/2025.

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. LABORATORIOS BEST SA's FEI number is 3024309112.

What types of violations has LABORATORIOS BEST SA received?

LABORATORIOS BEST 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 LABORATORIOS BEST SA come from?

All FDA import refusal data for LABORATORIOS BEST 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.