SANA COSMETICS CORP
⚠️ Moderate Risk
FEI: 3013301646 • Minato, Tokyo • JAPAN
FEI Number
3013301646
Location
Minato, Tokyo
Country
JAPANAddress
1 Chome 1-1, Minamiaoyama, Minato, 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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2011 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 3/9/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 3/9/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 7/26/2010 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 471CSTIC 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 SANA COSMETICS CORP's FDA import refusal history?
SANA COSMETICS CORP (FEI: 3013301646) has 5 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. SANA COSMETICS CORP's FEI number is 3013301646.
What types of violations has SANA COSMETICS CORP received?
SANA COSMETICS CORP 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 SANA COSMETICS CORP come from?
All FDA import refusal data for SANA COSMETICS CORP 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.