Top-Well Cosmetics Industry Co Ltd,
⚠️ Moderate Risk
FEI: 3002452433 • Taichung • TAIWAN
FEI Number
3002452433
Location
Taichung
Country
TAIWANAddress
Lane 71, No. 1-1 Fu-Te Rd, Taichung, , Taiwan
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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/1/2015 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 4/1/2015 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 6/7/2011 | 53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/14/2011 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 3280FRNMFGREG | Los Angeles District Office (LOS-DO) |
| 4/14/2011 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/13/2009 | 53CD03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 9/25/2009 | 53CD03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/26/2009 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 5/26/2009 | 53GH99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 8/30/2006 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/8/2006 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 2/8/2006 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 2/12/2003 | 53CH08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Top-Well Cosmetics Industry Co Ltd,'s FDA import refusal history?
Top-Well Cosmetics Industry Co Ltd, (FEI: 3002452433) has 13 FDA import refusal record(s) in our database, spanning from 2/12/2003 to 4/1/2015.
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. Top-Well Cosmetics Industry Co Ltd,'s FEI number is 3002452433.
What types of violations has Top-Well Cosmetics Industry Co Ltd, received?
Top-Well Cosmetics Industry Co Ltd, 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 Top-Well Cosmetics Industry Co Ltd, come from?
All FDA import refusal data for Top-Well Cosmetics Industry 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.