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Amorepacific Corporation

⚠️ Moderate Risk

FEI: 3004855944 • Yongsan-Ku, Seoul Teugbyeolsi • SOUTH KOREA

FEI

FEI Number

3004855944

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Location

Yongsan-Ku, Seoul Teugbyeolsi

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🏢

Address

2ka Hangang-Ro, , Yongsan-Ku, Seoul Teugbyeolsi, South Korea

Moderate Risk

FDA Import Risk Assessment

42.3
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
8/10/2018
Latest Refusal
12/20/2012
Earliest Refusal

Score Breakdown

Violation Severity
82.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
8.9×10%
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

754×

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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/10/2018
66PBP99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Southeast Imports (DSEI)
12/20/2012
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/20/2012
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/20/2012
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Amorepacific Corporation's FDA import refusal history?

Amorepacific Corporation (FEI: 3004855944) has 5 FDA import refusal record(s) in our database, spanning from 12/20/2012 to 8/10/2018.

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. Amorepacific Corporation's FEI number is 3004855944.

What types of violations has Amorepacific Corporation received?

Amorepacific Corporation 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 Amorepacific Corporation come from?

All FDA import refusal data for Amorepacific Corporation 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.