DONGKWANG PHARMACEUTICAL CO LTD
⚠️ Moderate Risk
FEI: 3014050538 • Seoul • SOUTH KOREA
FEI Number
3014050538
Location
Seoul
Country
SOUTH KOREAAddress
7f 97 Toegye-Ro, Jung, , Seoul, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is DONGKWANG PHARMACEUTICAL CO LTD's FDA import refusal history?
DONGKWANG PHARMACEUTICAL CO LTD (FEI: 3014050538) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2021 to 1/12/2021.
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. DONGKWANG PHARMACEUTICAL CO LTD's FEI number is 3014050538.
What types of violations has DONGKWANG PHARMACEUTICAL CO LTD received?
DONGKWANG PHARMACEUTICAL CO LTD has been cited for 3 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 DONGKWANG PHARMACEUTICAL CO LTD come from?
All FDA import refusal data for DONGKWANG PHARMACEUTICAL 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.