Eveline Cosmetics
⚠️ Moderate Risk
FEI: 3007842808 • Zytnia • POLAND
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/27/2011 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2011 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2011 | 61HAL99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2011 | 66PAO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2011 | 66PAO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2011 | 66PAO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Eveline Cosmetics's FDA import refusal history?
Eveline Cosmetics (FEI: 3007842808) has 14 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 10/27/2011.
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. Eveline Cosmetics's FEI number is 3007842808.
What types of violations has Eveline Cosmetics received?
Eveline Cosmetics has been cited for 8 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 Eveline Cosmetics come from?
All FDA import refusal data for Eveline Cosmetics 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.