Young Chemical Co., Ltd.
⚠️ High Risk
FEI: 3003196108 • Gimhae-Si, Gyeongnam • SOUTH KOREA
FEI Number
3003196108
Location
Gimhae-Si, Gyeongnam
Country
SOUTH KOREAAddress
80-93 Golden Root-Ro, Juchon-Myeon, Gimhae-Si, Gyeongnam, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 1/22/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 8/22/2024 | 79NADDRESSING, WOUND, OCCLUSIVE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/29/2022 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/15/2021 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/15/2021 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 10/1/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/1/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/1/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/1/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of Northeast Imports (DNEI) | |
| 10/1/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of Northeast Imports (DNEI) | |
| 9/18/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 9/18/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 8/11/2020 | 53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/4/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of Northeast Imports (DNEI) | |
| 8/4/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of Northeast Imports (DNEI) | |
| 8/4/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of Northeast Imports (DNEI) | |
| 8/4/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of Northeast Imports (DNEI) | |
| 4/9/2020 | 53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/9/2020 | 53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/9/2020 | 53LF08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 3/24/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 3/24/2020 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 9/5/2019 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3260NO ENGLISH | Division of Northeast Imports (DNEI) |
| 9/5/2019 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3260NO ENGLISH | Division of Northeast Imports (DNEI) |
| 9/5/2019 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3260NO ENGLISH | Division of Northeast Imports (DNEI) |
| 9/5/2019 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3260NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/30/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | Division of West Coast Imports (DWCI) | |
| 12/23/2011 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/7/2011 | 80NZIDRESSING, WOUND, DRUG | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Young Chemical Co., Ltd.'s FDA import refusal history?
Young Chemical Co., Ltd. (FEI: 3003196108) has 29 FDA import refusal record(s) in our database, spanning from 11/7/2011 to 1/22/2025.
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. Young Chemical Co., Ltd.'s FEI number is 3003196108.
What types of violations has Young Chemical Co., Ltd. received?
Young Chemical Co., Ltd. has been cited for 9 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 Young Chemical Co., Ltd. come from?
All FDA import refusal data for Young Chemical 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.