ImportRefusal LogoImportRefusal

MEGAGEN IMPLANT CO

✅ Low Risk

FEI: 3014151279 • Dalseong, Daegu • SOUTH KOREA

FEI

FEI Number

3014151279

📍

Location

Dalseong, Daegu

🇰🇷
🏢

Address

45 Secheonro7-Gil, Dasa-Eup, Dalseong, Daegu, South Korea

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
2/26/2021
Latest Refusal
2/26/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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
2/26/2021
76DZEIMPLANT, ENDOSSEOUS
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MEGAGEN IMPLANT CO's FDA import refusal history?

MEGAGEN IMPLANT CO (FEI: 3014151279) has 1 FDA import refusal record(s) in our database, spanning from 2/26/2021 to 2/26/2021.

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. MEGAGEN IMPLANT CO's FEI number is 3014151279.

What types of violations has MEGAGEN IMPLANT CO received?

MEGAGEN IMPLANT CO 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 MEGAGEN IMPLANT CO come from?

All FDA import refusal data for MEGAGEN IMPLANT CO 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.