Hankook Cosmetics Manufacturing Co., Ltd
⚠️ Moderate Risk
FEI: 3012656014 • Eumseong, Chungcheongbuk • SOUTH KOREA
FEI Number
3012656014
Location
Eumseong, Chungcheongbuk
Country
SOUTH KOREAAddress
74 Daeseongro547beon-Gil, Samseong-Myeon, Eumseong, Chungcheongbuk, 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
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2025 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/16/2024 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2019 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 336INCONSPICU | Division of West Coast Imports (DWCI) |
| 8/30/2019 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 336INCONSPICU | Division of West Coast Imports (DWCI) |
| 8/16/2019 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hankook Cosmetics Manufacturing Co., Ltd's FDA import refusal history?
Hankook Cosmetics Manufacturing Co., Ltd (FEI: 3012656014) has 6 FDA import refusal record(s) in our database, spanning from 8/16/2019 to 4/10/2025.
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. Hankook Cosmetics Manufacturing Co., Ltd's FEI number is 3012656014.
What types of violations has Hankook Cosmetics Manufacturing Co., Ltd received?
Hankook Cosmetics Manufacturing 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 Hankook Cosmetics Manufacturing Co., Ltd come from?
All FDA import refusal data for Hankook Cosmetics Manufacturing 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.