Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd
⚠️ Moderate Risk
FEI: 3008389820 • Shenzhen • CHINA
FEI Number
3008389820
Location
Shenzhen
Country
CHINAAddress
412 Shenzhen Huaqiang North Road,, R, Shenzhen, , China
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.
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.
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.
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 |
|---|---|---|---|
| 9/13/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New England District Office (NWE-DO) | |
| 9/13/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New England District Office (NWE-DO) | |
| 9/13/2010 | 60CBJ09PHENYLEPHRINE HCL (ADRENERGIC) | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd's FDA import refusal history?
Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd (FEI: 3008389820) has 3 FDA import refusal record(s) in our database, spanning from 9/13/2010 to 9/13/2010.
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. Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd's FEI number is 3008389820.
What types of violations has Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd received?
Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd 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 Yue-Sai Kan Cosmetics (Shenzhen) Co., Ltd come from?
All FDA import refusal data for Yue-Sai Kan Cosmetics (Shenzhen) 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.