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AEKYUNG INDUSTRIAL CO., LTD

⚠️ Moderate Risk

FEI: 3015485107 • Mapo, Seoul • SOUTH KOREA

FEI

FEI Number

3015485107

📍

Location

Mapo, Seoul

🇰🇷
🏢

Address

10f~13f, 2f (Aekyung To, 188 Yanghwa-Ro, Mapo, Seoul, South Korea

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/8/2022
Latest Refusal
6/8/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
14.1×20%
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
6/8/2022
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is AEKYUNG INDUSTRIAL CO., LTD's FDA import refusal history?

AEKYUNG INDUSTRIAL CO., LTD (FEI: 3015485107) has 1 FDA import refusal record(s) in our database, spanning from 6/8/2022 to 6/8/2022.

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. AEKYUNG INDUSTRIAL CO., LTD's FEI number is 3015485107.

What types of violations has AEKYUNG INDUSTRIAL CO., LTD received?

AEKYUNG INDUSTRIAL CO., LTD 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 AEKYUNG INDUSTRIAL CO., LTD come from?

All FDA import refusal data for AEKYUNG INDUSTRIAL CO., LTD 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.