Isehan Inc
⚠️ Moderate Risk
FEI: 3011296499 • Chiyoda, Tokyo • JAPAN
FEI Number
3011296499
Location
Chiyoda, Tokyo
Country
JAPANAddress
6-11, Yonban-Cho, Chiyoda, Tokyo, Japan
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 6/9/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/9/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 4/8/2019 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Isehan Inc's FDA import refusal history?
Isehan Inc (FEI: 3011296499) has 5 FDA import refusal record(s) in our database, spanning from 4/8/2019 to 6/9/2025.
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. Isehan Inc's FEI number is 3011296499.
What types of violations has Isehan Inc received?
Isehan Inc has been cited for 3 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 Isehan Inc come from?
All FDA import refusal data for Isehan Inc 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.