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Median Diagnostics Inc

⚠️ High Risk

FEI: 3010793281 • Chuncheon, Gangwon • SOUTH KOREA

FEI

FEI Number

3010793281

📍

Location

Chuncheon, Gangwon

🇰🇷
🏢

Address

878 Sunhwandae-Ro, Dongnae-Myeon, Chuncheon, Gangwon, South Korea

High Risk

FDA Import Risk Assessment

54.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/3/2024
Latest Refusal
9/3/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
72.6×20%
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
9/3/2024
57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Median Diagnostics Inc's FDA import refusal history?

Median Diagnostics Inc (FEI: 3010793281) has 1 FDA import refusal record(s) in our database, spanning from 9/3/2024 to 9/3/2024.

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. Median Diagnostics Inc's FEI number is 3010793281.

What types of violations has Median Diagnostics Inc received?

Median Diagnostics Inc 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 Median Diagnostics Inc come from?

All FDA import refusal data for Median Diagnostics Inc 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.