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Br Internation Co

⚠️ High Risk

FEI: 3011771357 • Seoul • SOUTH KOREA

FEI

FEI Number

3011771357

📍

Location

Seoul

🇰🇷
🏢

Address

221 Hyun Dai Park Ville, 41 Gongwon Ro, , Seoul, , South Korea

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
1
Unique Violations
12/12/2016
Latest Refusal
12/12/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

757×

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
12/12/2016
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/12/2016
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/12/2016
53LC07NIGHT (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/12/2016
53LC07NIGHT (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/12/2016
53LC07NIGHT (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/12/2016
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/12/2016
53LC07NIGHT (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Br Internation Co's FDA import refusal history?

Br Internation Co (FEI: 3011771357) has 7 FDA import refusal record(s) in our database, spanning from 12/12/2016 to 12/12/2016.

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. Br Internation Co's FEI number is 3011771357.

What types of violations has Br Internation Co received?

Br Internation 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 Br Internation Co come from?

All FDA import refusal data for Br Internation 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.