B&C
⚠️ High Risk
FEI: 3005738945 • Minato, Tokyo • JAPAN
FEI Number
3005738945
Location
Minato, Tokyo
Country
JAPANAddress
5 Chome 12-7, Shirokane, Minato, 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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2011 | 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) |
| 2/28/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 8/25/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 7/26/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 7/13/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 7/13/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 7/13/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/25/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/25/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/24/2010 | 53CG02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/6/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 198COLOR LBLG | 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 B&C's FDA import refusal history?
B&C (FEI: 3005738945) has 13 FDA import refusal record(s) in our database, spanning from 5/4/2010 to 6/22/2011.
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. B&C's FEI number is 3005738945.
What types of violations has B&C received?
B&C 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 B&C come from?
All FDA import refusal data for B&C 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.