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Medimexico, S. de R.L. de C.V.

⚠️ Moderate Risk

FEI: 3002654698 • Tijuana, Baja California • MEXICO

FEI

FEI Number

3002654698

📍

Location

Tijuana, Baja California

🇲🇽

Country

MEXICO
🏢

Address

Privada Imperial No 10523, Col. Colinas Del Rey, Tijuana, Tijuana, Baja California, Mexico

Moderate Risk

FDA Import Risk Assessment

33.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/13/2023
Latest Refusal
4/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
44.5×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
4/13/2023
78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Medimexico, S. de R.L. de C.V.'s FDA import refusal history?

Medimexico, S. de R.L. de C.V. (FEI: 3002654698) has 1 FDA import refusal record(s) in our database, spanning from 4/13/2023 to 4/13/2023.

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. Medimexico, S. de R.L. de C.V.'s FEI number is 3002654698.

What types of violations has Medimexico, S. de R.L. de C.V. received?

Medimexico, S. de R.L. de C.V. 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 Medimexico, S. de R.L. de C.V. come from?

All FDA import refusal data for Medimexico, S. de R.L. de C.V. 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.