KOJI HONPO CO.,LTD
⚠️ High Risk
FEI: 3012299637 • Taito, Tokyo • JAPAN
FEI Number
3012299637
Location
Taito, Tokyo
Country
JAPANAddress
2 Chome 26-1, Matsugaya, Taito, Tokyo, Japan
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
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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2024 | 53CD13EYELASH AND EYEBROW ADHESIVE (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 5/11/2016 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/11/2016 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/11/2016 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/11/2016 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/11/2016 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/8/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 4/24/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 12/21/2011 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/22/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/22/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/22/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/22/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/22/2011 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 3/24/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 3/24/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 3/9/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 3/9/2011 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 3/9/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 8/25/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 8/25/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 7/13/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 7/13/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/25/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is KOJI HONPO CO.,LTD's FDA import refusal history?
KOJI HONPO CO.,LTD (FEI: 3012299637) has 32 FDA import refusal record(s) in our database, spanning from 5/4/2010 to 8/22/2024.
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. KOJI HONPO CO.,LTD's FEI number is 3012299637.
What types of violations has KOJI HONPO CO.,LTD received?
KOJI HONPO CO.,LTD 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 KOJI HONPO CO.,LTD come from?
All FDA import refusal data for KOJI HONPO 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.