Adwin Korea Corp.
⚠️ Moderate Risk
FEI: 3004102812 • kangnam Gu, Seoul • SOUTH KOREA
FEI Number
3004102812
Location
kangnam Gu, Seoul
Country
SOUTH KOREAAddress
4F Dong-A Bldg.,, 769-7 Yoksam-dong, kangnam Gu, 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
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).
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2020 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/24/2020 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/27/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 4/30/2018 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 4/25/2018 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/16/2018 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/13/2017 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/29/2017 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/29/2017 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/28/2017 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/6/2017 | 63VBJ99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/6/2017 | 62SBJ99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/27/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 6/22/2010 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/1/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 6/1/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 8/7/2009 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Seattle District Office (SEA-DO) | |
| 12/28/2005 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Adwin Korea Corp.'s FDA import refusal history?
Adwin Korea Corp. (FEI: 3004102812) has 20 FDA import refusal record(s) in our database, spanning from 12/28/2005 to 11/24/2020.
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. Adwin Korea Corp.'s FEI number is 3004102812.
What types of violations has Adwin Korea Corp. received?
Adwin Korea Corp. 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 Adwin Korea Corp. come from?
All FDA import refusal data for Adwin Korea Corp. 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.