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HANMI PHARM. CO., LTD.

⚠️ High Risk

FEI: 3003040331 • Hwaseong, Gyeonggi • SOUTH KOREA

FEI

FEI Number

3003040331

📍

Location

Hwaseong, Gyeonggi

🇰🇷
🏢

Address

214 Muha-Ro, Paltan-Myeon, Hwaseong, Gyeonggi, South Korea

High Risk

FDA Import Risk Assessment

51.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/22/2025
Latest Refusal
8/28/2007
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
77.7×20%
Frequency
1.1×10%
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

752×

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
8/22/2025
64XDY11ISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/28/2007
62ODB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is HANMI PHARM. CO., LTD.'s FDA import refusal history?

HANMI PHARM. CO., LTD. (FEI: 3003040331) has 2 FDA import refusal record(s) in our database, spanning from 8/28/2007 to 8/22/2025.

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. HANMI PHARM. CO., LTD.'s FEI number is 3003040331.

What types of violations has HANMI PHARM. CO., LTD. received?

HANMI PHARM. 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 HANMI PHARM. CO., LTD. come from?

All FDA import refusal data for HANMI PHARM. 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.