Koreana Cosmetics Co., Ltd.
⚠️ Moderate Risk
FEI: 1000277041 • Seoul • SOUTH KOREA
FEI Number
1000277041
Location
Seoul
Country
SOUTH KOREAAddress
Koreana Bldg 1422-7 Sego-Dong, , 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).
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2025 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/17/2005 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 11/17/2005 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Koreana Cosmetics Co., Ltd.'s FDA import refusal history?
Koreana Cosmetics Co., Ltd. (FEI: 1000277041) has 3 FDA import refusal record(s) in our database, spanning from 11/17/2005 to 3/14/2025.
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. Koreana Cosmetics Co., Ltd.'s FEI number is 1000277041.
What types of violations has Koreana Cosmetics Co., Ltd. received?
Koreana Cosmetics 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 Koreana Cosmetics Co., Ltd. come from?
All FDA import refusal data for Koreana Cosmetics 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.