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H & K Korea Corp.

⚠️ Moderate Risk

FEI: 3009757627 • Seoul • SOUTH KOREA

FEI

FEI Number

3009757627

📍

Location

Seoul

🇰🇷
🏢

Address

No. 307 3f Woori Bldg. 47-17 Sin, , Seoul, , 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
3
Unique Violations
12/21/2012
Latest Refusal
12/21/2012
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

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
12/21/2012
53CY04EYE LOTION (EYE MAKEUP PREPARATIONS)
310POISONOUS
471CSTIC LBLG
475COSMETLBLG
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is H & K Korea Corp.'s FDA import refusal history?

H & K Korea Corp. (FEI: 3009757627) has 1 FDA import refusal record(s) in our database, spanning from 12/21/2012 to 12/21/2012.

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. H & K Korea Corp.'s FEI number is 3009757627.

What types of violations has H & K Korea Corp. received?

H & K Korea Corp. has been cited for 3 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 H & K Korea Corp. come from?

All FDA import refusal data for H & K Korea 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.