HANKOOK COSMETICS MANUFACTURING CO.,LTD.
⚠️ Moderate Risk
FEI: 3010191395 • Seoul, Seoul • SOUTH KOREA
FEI Number
3010191395
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
Seorin Bldg, 88 Seorin-dong, Jongno-gu, Seoul, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 8/24/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 12/7/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 12/7/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 12/7/2005 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/7/2005 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/7/2005 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/7/2005 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/7/2005 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/7/2005 | 66PDR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 53CK01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 66PBE99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 66PBE99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 66PBE99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/4/2005 | 66PBE99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/3/2005 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/29/2004 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/7/2001 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is HANKOOK COSMETICS MANUFACTURING CO.,LTD.'s FDA import refusal history?
HANKOOK COSMETICS MANUFACTURING CO.,LTD. (FEI: 3010191395) has 17 FDA import refusal record(s) in our database, spanning from 12/7/2001 to 8/24/2010.
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. HANKOOK COSMETICS MANUFACTURING CO.,LTD.'s FEI number is 3010191395.
What types of violations has HANKOOK COSMETICS MANUFACTURING CO.,LTD. received?
HANKOOK COSMETICS MANUFACTURING CO.,LTD. has been cited for 5 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.