Hanbul Cosmetics Co.
⚠️ High Risk
FEI: 1000613595 • Seoul • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/11/2010 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/14/2010 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/14/2010 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/14/2010 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53GC06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 2/27/2009 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/27/2009 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/6/2008 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/27/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/27/2008 | 53GC06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/27/2008 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/27/2008 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/28/2005 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/28/2005 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/28/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/28/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/28/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/28/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hanbul Cosmetics Co.'s FDA import refusal history?
Hanbul Cosmetics Co. (FEI: 1000613595) has 32 FDA import refusal record(s) in our database, spanning from 7/28/2005 to 8/11/2010.
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. Hanbul Cosmetics Co.'s FEI number is 1000613595.
What types of violations has Hanbul Cosmetics Co. received?
Hanbul Cosmetics Co. has been cited for 2 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 Hanbul Cosmetics Co. come from?
All FDA import refusal data for Hanbul Cosmetics Co. 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.