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MEDERI LAB SAPI DE CV

⚠️ High Risk

FEI: 3023873345 • Jalisco • MEXICO

FEI

FEI Number

3023873345

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Metalurgia No 2820 Parq, , Jalisco, , Mexico

High Risk

FDA Import Risk Assessment

59.2
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
9/23/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
79.6×20%
Frequency
20.0×10%
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

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
56BML03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/23/2025
61LLL14CHLORHEXIDINE GLUCONATE
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MEDERI LAB SAPI DE CV's FDA import refusal history?

MEDERI LAB SAPI DE CV (FEI: 3023873345) has 2 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. MEDERI LAB SAPI DE CV's FEI number is 3023873345.

What types of violations has MEDERI LAB SAPI DE CV received?

MEDERI LAB SAPI 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 MEDERI LAB SAPI DE CV come from?

All FDA import refusal data for MEDERI LAB SAPI 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.