4e De Mexico Sa De Cv
⚠️ Moderate Risk
FEI: 3010078536 • Naucalpan de Juarez, Mexico • MEXICO
FEI Number
3010078536
Location
Naucalpan de Juarez, Mexico
Country
MEXICOAddress
Calle Paseo Alexander von Humboldt 43a, Fracc. LOMAS VERDES 3RA SECC, Naucalpan de Juarez, Mexico, 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
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
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).
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/6/2014 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 1/31/2014 | 62HAY99ANTI-MICROBIAL N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/31/2014 | 62HAY99ANTI-MICROBIAL N.E.C. | 178COL ADDED | Southwest Import District Office (SWI-DO) |
| 1/31/2014 | 62HAY99ANTI-MICROBIAL N.E.C. | 178COL ADDED | Southwest Import District Office (SWI-DO) |
| 1/31/2014 | 62HAY99ANTI-MICROBIAL N.E.C. | 178COL ADDED | Southwest Import District Office (SWI-DO) |
| 1/31/2014 | 62HAY99ANTI-MICROBIAL N.E.C. | 178COL ADDED | Southwest Import District Office (SWI-DO) |
| 7/23/2013 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is 4e De Mexico Sa De Cv's FDA import refusal history?
4e De Mexico Sa De Cv (FEI: 3010078536) has 7 FDA import refusal record(s) in our database, spanning from 7/23/2013 to 2/6/2014.
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. 4e De Mexico Sa De Cv's FEI number is 3010078536.
What types of violations has 4e De Mexico Sa De Cv received?
4e De Mexico Sa De Cv has been cited for 5 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 4e De Mexico Sa De Cv come from?
All FDA import refusal data for 4e De Mexico 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.