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Unique International Co. Ltd.

⚠️ Moderate Risk

FEI: 3007607020 • Gangwon-Do • SOUTH KOREA

FEI

FEI Number

3007607020

📍

Location

Gangwon-Do

🇰🇷
🏢

Address

477 Janghak-Ri, Dong-Myeon, Chuncheon-Si, Gangwon-Do, , 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
2
Unique Violations
2/10/2009
Latest Refusal
2/10/2009
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
2/10/2009
66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
472NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Unique International Co. Ltd.'s FDA import refusal history?

Unique International Co. Ltd. (FEI: 3007607020) has 1 FDA import refusal record(s) in our database, spanning from 2/10/2009 to 2/10/2009.

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. Unique International Co. Ltd.'s FEI number is 3007607020.

What types of violations has Unique International Co. Ltd. received?

Unique International Co. Ltd. has been cited for 2 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 Unique International Co. Ltd. come from?

All FDA import refusal data for Unique International 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.