GDK Cosmetics Co., Ltd.
⚠️ High Risk
FEI: 3009900943 • Namdong, Incheon • SOUTH KOREA
FEI Number
3009900943
Location
Namdong, Incheon
Country
SOUTH KOREAAddress
100 Eunbong-Ro, , Namdong, Incheon, 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
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/17/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 308MFR INSAN | Division of Northeast Imports (DNEI) |
| 11/12/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 9/25/2025 | 66XDY04HOMEOPATHIC DERMATOLOGICAL | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/9/2025 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 3600REFUSE EI | Division of Northern Border Imports (DNBI) |
| 5/9/2025 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of Northern Border Imports (DNBI) |
| 5/9/2025 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of Northern Border Imports (DNBI) |
| 4/16/2025 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 2/20/2025 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 2/20/2025 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 6/25/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 2/14/2024 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 11/15/2022 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 3/23/2022 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 1/13/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
| 2/4/2021 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 1/5/2021 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/9/2020 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 8/4/2020 | 53CY99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 11/19/2019 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of Southwest Imports (DSWI) |
| 11/19/2019 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is GDK Cosmetics Co., Ltd.'s FDA import refusal history?
GDK Cosmetics Co., Ltd. (FEI: 3009900943) has 28 FDA import refusal record(s) in our database, spanning from 11/19/2019 to 11/20/2025.
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. GDK Cosmetics Co., Ltd.'s FEI number is 3009900943.
What types of violations has GDK Cosmetics Co., Ltd. received?
GDK Cosmetics Co., Ltd. has been cited for 6 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 GDK Cosmetics Co., Ltd. come from?
All FDA import refusal data for GDK 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.