Cosmax Inc
⚠️ High Risk
FEI: 3010581338 • Gyeonggi-do, Gyeonggi-do • SOUTH KOREA
FEI Number
3010581338
Location
Gyeonggi-do, Gyeonggi-do
Country
SOUTH KOREAAddress
27, Jeyakgongdan 1-gil, Hwaseong, Gyeonggi-do, Gyeonggi-do, 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).
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2025 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/27/2025 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/24/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/19/2025 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | 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) |
| 9/19/2025 | 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) |
| 9/19/2025 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2025 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/8/2025 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/30/2025 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 7/29/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 7/29/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2025 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 6/20/2025 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
| 10/22/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/25/2024 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/30/2024 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 12/20/2023 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/6/2019 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 1/29/2019 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 12/13/2017 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 473LABELING | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Cosmax Inc's FDA import refusal history?
Cosmax Inc (FEI: 3010581338) has 26 FDA import refusal record(s) in our database, spanning from 12/13/2017 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. Cosmax Inc's FEI number is 3010581338.
What types of violations has Cosmax Inc received?
Cosmax Inc has been cited for 7 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 Cosmax Inc come from?
All FDA import refusal data for Cosmax Inc 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.