Hugel Inc.
⚠️ High Risk
FEI: 3012163998 • Chuncheon, Gangwon • SOUTH KOREA
FEI Number
3012163998
Location
Chuncheon, Gangwon
Country
SOUTH KOREAAddress
23 Geodudanji1-Gil, Dongnae-Myeon, Chuncheon, Gangwon, 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
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.
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2025 | 58PCZ05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 10/21/2025 | 58PCZ05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2025 | 58PCZ05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 1/4/2021 | 65QCP02BOTOX | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hugel Inc.'s FDA import refusal history?
Hugel Inc. (FEI: 3012163998) has 4 FDA import refusal record(s) in our database, spanning from 1/4/2021 to 10/29/2025.
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. Hugel Inc.'s FEI number is 3012163998.
What types of violations has Hugel Inc. received?
Hugel Inc. has been cited for 7 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 Hugel Inc. come from?
All FDA import refusal data for Hugel Inc. 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.