Intercos Europe S.p.A
⚠️ High Risk
FEI: 1000181428 • Agrate Brianza, Monza E della Brianza • ITALY
FEI Number
1000181428
Location
Agrate Brianza, Monza E della Brianza
Country
ITALYAddress
Via Guglielmo Marconi 84, , Agrate Brianza, Monza E della Brianza, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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.
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2024 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 6/27/2024 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 5/6/2024 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 5/1/2024 | 53GG05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of Northeast Imports (DNEI) | |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 3881COSMETFPLA | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 3881COSMETFPLA | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 8/20/2019 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 5/1/2018 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 5/1/2018 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 7/9/2013 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | Division of Northeast Imports (DNEI) | |
| 6/29/2012 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/21/2010 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 12/21/2010 | 53YH99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 12/21/2010 | 53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 12/21/2010 | 53YH99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New York District Office (NYK-DO) | |
| 1/2/2008 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 8/27/2004 | 53CC05EYE MAKEUP REMOVER (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Intercos Europe S.p.A's FDA import refusal history?
Intercos Europe S.p.A (FEI: 1000181428) has 25 FDA import refusal record(s) in our database, spanning from 8/27/2004 to 7/9/2024.
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. Intercos Europe S.p.A's FEI number is 1000181428.
What types of violations has Intercos Europe S.p.A received?
Intercos Europe S.p.A has been cited for 7 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 Intercos Europe S.p.A come from?
All FDA import refusal data for Intercos Europe S.p.A 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.