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M BIOMEDICA

⚠️ High Risk

FEI: 3032004620 • Ibague, Tolima • COLOMBIA

FEI

FEI Number

3032004620

📍

Location

Ibague, Tolima

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 60 6 Bis 51 B, , Ibague, Tolima, Colombia

High Risk

FDA Import Risk Assessment

61.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
9/16/2024
Latest Refusal
9/16/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
59.1×20%
Frequency
50.0×10%
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

755×

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
9/16/2024
62GDK99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/16/2024
62GDK99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/16/2024
62GDK99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/16/2024
62GDK99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/16/2024
61PDA99ANTI-DIABETIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is M BIOMEDICA's FDA import refusal history?

M BIOMEDICA (FEI: 3032004620) has 5 FDA import refusal record(s) in our database, spanning from 9/16/2024 to 9/16/2024.

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. M BIOMEDICA's FEI number is 3032004620.

What types of violations has M BIOMEDICA received?

M BIOMEDICA 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 M BIOMEDICA come from?

All FDA import refusal data for M BIOMEDICA 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.