Zermat Internacional Sa De Cv
⚠️ Moderate Risk
FEI: 3009710272 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3009710272
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Torre 3, Circuito Interior (Calzada Melchor Ocampo); Col. Veronica Anzures, Miguel Hidalgo, Ciudad De Mexico, Ciudad de 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
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).
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.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2020 | 53UC10PERSONAL CLEANLINESS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 11/1/2018 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 8/19/2014 | 29YGY99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 2300DIETARYLBL | Southwest Import District Office (SWI-DO) |
| 5/15/2013 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Southwest Import District Office (SWI-DO) | |
| 2/27/2013 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 2/27/2013 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/20/2012 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/20/2012 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/20/2012 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 11/16/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/16/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/16/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/16/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/31/2012 | 53JG02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/31/2012 | 53JL02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/31/2012 | 53JG02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/24/2012 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/24/2012 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/24/2012 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Zermat Internacional Sa De Cv's FDA import refusal history?
Zermat Internacional Sa De Cv (FEI: 3009710272) has 19 FDA import refusal record(s) in our database, spanning from 10/24/2012 to 5/12/2020.
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. Zermat Internacional Sa De Cv's FEI number is 3009710272.
What types of violations has Zermat Internacional Sa De Cv received?
Zermat Internacional 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 Zermat Internacional Sa De Cv come from?
All FDA import refusal data for Zermat Internacional 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.