DUKSAN PURE CHEMICALS CO., LTD.
⚠️ High Risk
FEI: 3016842646 • Ansan • SOUTH KOREA
FEI Number
3016842646
Location
Ansan
Country
SOUTH KOREAAddress
Beon-Gil, Danwon, 133 53 Sinwon-Ro, Ansan, , South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is DUKSAN PURE CHEMICALS CO., LTD.'s FDA import refusal history?
DUKSAN PURE CHEMICALS CO., LTD. (FEI: 3016842646) has 2 FDA import refusal record(s) in our database, spanning from 11/13/2025 to 1/2/2026.
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. DUKSAN PURE CHEMICALS CO., LTD.'s FEI number is 3016842646.
What types of violations has DUKSAN PURE CHEMICALS CO., LTD. received?
DUKSAN PURE CHEMICALS CO., LTD. has been cited for 4 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 DUKSAN PURE CHEMICALS CO., LTD. come from?
All FDA import refusal data for DUKSAN PURE CHEMICALS 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.