Cosmelab Co Ltd
⚠️ Moderate Risk
FEI: 3009647084 • Gangnam, Seoul • SOUTH KOREA
FEI Number
3009647084
Location
Gangnam, Seoul
Country
SOUTH KOREAAddress
Gangnam Cl B/D, 42 Teheranro32-Gil, Gangnam, Seoul, South Korea
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2017 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 12/22/2016 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) | |
| 12/22/2016 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) | |
| 12/22/2016 | 53CD01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/22/2016 | 53CD01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/7/2016 | 53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 12/7/2016 | 53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 11/18/2016 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Cosmelab Co Ltd's FDA import refusal history?
Cosmelab Co Ltd (FEI: 3009647084) has 8 FDA import refusal record(s) in our database, spanning from 11/18/2016 to 3/20/2017.
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. Cosmelab Co Ltd's FEI number is 3009647084.
What types of violations has Cosmelab Co Ltd received?
Cosmelab 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 Cosmelab Co Ltd come from?
All FDA import refusal data for Cosmelab 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.