MILBON
⚠️ High Risk
FEI: 3014381542 • Chuo, Tokyo • JAPAN
FEI Number
3014381542
Location
Chuo, Tokyo
Country
JAPANAddress
2 Chome 1, Kyobashi2, Chuo, 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
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.
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 |
|---|---|---|---|
| 12/17/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 474COSMETLBLG | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 474COSMETLBLG | Division of Southeast Imports (DSEI) |
| 10/10/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 10/10/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 9/25/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 9/11/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 11/22/2023 | 53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2023 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MILBON's FDA import refusal history?
MILBON (FEI: 3014381542) has 9 FDA import refusal record(s) in our database, spanning from 11/22/2023 to 12/17/2024.
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. MILBON's FEI number is 3014381542.
What types of violations has MILBON received?
MILBON 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 MILBON come from?
All FDA import refusal data for MILBON 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.