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Prime Meditech Corp

⚠️ Moderate Risk

FEI: 3007604480 • Buchonbuchon • SOUTH KOREA

FEI

FEI Number

3007604480

📍

Location

Buchonbuchon

🇰🇷
🏢

Address

48-72 Sam Jung Dong, , Buchonbuchon, , South Korea

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/7/2012
Latest Refusal
11/7/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
11/7/2012
79GFDDERMATOME
223FALSE
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Prime Meditech Corp's FDA import refusal history?

Prime Meditech Corp (FEI: 3007604480) has 1 FDA import refusal record(s) in our database, spanning from 11/7/2012 to 11/7/2012.

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. Prime Meditech Corp's FEI number is 3007604480.

What types of violations has Prime Meditech Corp received?

Prime Meditech Corp 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 Prime Meditech Corp come from?

All FDA import refusal data for Prime Meditech Corp 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.