ITEL COSMETICOS SA DE CV
⚠️ Moderate Risk
FEI: 3012324472 • Naucalpan • MEXICO
FEI Number
3012324472
Location
Naucalpan
Country
MEXICOAddress
Colina de Las Gacelas #, , Naucalpan, , Mexico
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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/19/2016 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 7/19/2016 | 53DD99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 7/19/2016 | 53DD99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 7/19/2016 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 7/19/2016 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is ITEL COSMETICOS SA DE CV's FDA import refusal history?
ITEL COSMETICOS SA DE CV (FEI: 3012324472) has 5 FDA import refusal record(s) in our database, spanning from 7/19/2016 to 7/19/2016.
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. ITEL COSMETICOS SA DE CV's FEI number is 3012324472.
What types of violations has ITEL COSMETICOS SA DE CV received?
ITEL COSMETICOS SA DE CV 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 ITEL COSMETICOS SA DE CV come from?
All FDA import refusal data for ITEL COSMETICOS SA DE CV 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.