Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)
⚠️ High Risk
FEI: 3012333115 • Hwaseong, Gyeonggi • SOUTH KOREA
FEI Number
3012333115
Location
Hwaseong, Gyeonggi
Country
SOUTH KOREAAddress
Hyangnam-Eub, 35-14 Jeyakgongdan4-Gil; Hyangnam-Eup, Hwaseong, Gyeonggi, 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).
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/20/2026 | 58PCZ05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 6/30/2025 | 58PCZ05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/13/2024 | 58PCP05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)'s FDA import refusal history?
Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) (FEI: 3012333115) has 3 FDA import refusal record(s) in our database, spanning from 6/13/2024 to 1/20/2026.
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. Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)'s FEI number is 3012333115.
What types of violations has Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) received?
Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) 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 Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) come from?
All FDA import refusal data for Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) 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.