Cosmecca Korea Co., Ltd.
🚨 Critical Risk
FEI: 3010165567 • Eumseong, Chungcheongbuk • SOUTH KOREA
FEI Number
3010165567
Location
Eumseong, Chungcheongbuk
Country
SOUTH KOREAAddress
17-12 Daegeumro196beon-Gil, Daeso-Myeon, Eumseong, Chungcheongbuk, South Korea
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
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).
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).
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.
SOAKED/WET
The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health in that it appears to been held in water.
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.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 11/10/2025 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2025 | 66PIL05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 10/6/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/29/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/25/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/19/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/13/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/15/2025 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/3/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/26/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/26/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/26/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/26/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/26/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/19/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/6/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/5/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/5/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/5/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/5/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/5/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/3/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/17/2025 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/17/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 12/17/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2024 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/3/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 12/3/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 12/3/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 10/22/2024 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/22/2024 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/22/2024 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/7/2024 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/9/2024 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/30/2024 | 66PBJ16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 7/30/2024 | 66PBJ16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 7/30/2024 | 66PBJ16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 7/17/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/15/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 5/15/2024 | 53LF06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/29/2024 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/23/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 1/3/2024 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/30/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 9/15/2023 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/1/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 5/31/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/31/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/31/2023 | 53LK99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/16/2023 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 12/19/2022 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/1/2022 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 2/10/2022 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/10/2022 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 2/26/2021 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 2/17/2021 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 8/6/2020 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 152SOAKED/WET | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 152SOAKED/WET | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 152SOAKED/WET | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 152SOAKED/WET | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 152SOAKED/WET | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53GD07ROUGES (MAKEUP PREPARATIONS, NOT FOR EYES) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/6/2020 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/3/2020 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | Division of West Coast Imports (DWCI) |
| 4/3/2020 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | Division of West Coast Imports (DWCI) |
| 4/3/2020 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | Division of West Coast Imports (DWCI) |
| 3/26/2020 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 3/26/2020 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/6/2020 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 1/15/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/19/2018 | 65LAY99PROTECTANT N.E.C. | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/19/2018 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/19/2018 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/6/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/6/2018 | 53GC06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/6/2018 | 53GC06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/6/2018 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 8/9/2016 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Cosmecca Korea Co., Ltd.'s FDA import refusal history?
Cosmecca Korea Co., Ltd. (FEI: 3010165567) has 103 FDA import refusal record(s) in our database, spanning from 8/7/2015 to 12/22/2025.
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. Cosmecca Korea Co., Ltd.'s FEI number is 3010165567.
What types of violations has Cosmecca Korea Co., Ltd. received?
Cosmecca Korea Co., Ltd. has been cited for 13 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 Cosmecca Korea Co., Ltd. come from?
All FDA import refusal data for Cosmecca Korea 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.