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Chong Kun Dang Pharmaceutical Corp.

⚠️ High Risk

FEI: 3013662506 • SeoBuk, Cheonan • SOUTH KOREA

FEI

FEI Number

3013662506

📍

Location

SeoBuk, Cheonan

🇰🇷
🏢

Address

797-48 Manghyang-ro, Seonggeo-eup, , SeoBuk, Cheonan, South Korea

High Risk

FDA Import Risk Assessment

54.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/21/2024
Latest Refusal
8/21/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
71.8×20%
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
8/21/2024
62GDY99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Chong Kun Dang Pharmaceutical Corp.'s FDA import refusal history?

Chong Kun Dang Pharmaceutical Corp. (FEI: 3013662506) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2024 to 8/21/2024.

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. Chong Kun Dang Pharmaceutical Corp.'s FEI number is 3013662506.

What types of violations has Chong Kun Dang Pharmaceutical Corp. received?

Chong Kun Dang Pharmaceutical Corp. 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 Chong Kun Dang Pharmaceutical Corp. come from?

All FDA import refusal data for Chong Kun Dang Pharmaceutical 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.