Welcos Co., Ltd.
⚠️ Moderate Risk
FEI: 3011014087 • Chuncheon, Gangwon • SOUTH KOREA
FEI Number
3011014087
Location
Chuncheon, Gangwon
Country
SOUTH KOREAAddress
21-12 Toegyegongdan1-Gil, , Chuncheon, Gangwon, 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
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2020 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/21/2020 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 9/28/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LB06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/28/2010 | 53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/21/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/21/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Welcos Co., Ltd.'s FDA import refusal history?
Welcos Co., Ltd. (FEI: 3011014087) has 19 FDA import refusal record(s) in our database, spanning from 8/21/2008 to 11/4/2020.
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. Welcos Co., Ltd.'s FEI number is 3011014087.
What types of violations has Welcos Co., Ltd. received?
Welcos Co., Ltd. has been cited for 4 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 Welcos Co., Ltd. come from?
All FDA import refusal data for Welcos 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.