QUALMEX SA DE CV
⚠️ Moderate Risk
FEI: 3013728639 • Toluca, Mexico • MEXICO
FEI Number
3013728639
Location
Toluca, Mexico
Country
MEXICOAddress
Calle 6 Norte Numero 11, , Toluca, 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
INCONSPICU
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2025 | 29FGT99ENERGY DRINK CAFFEINE, CARBONATED, N.E.C. | 324NO ENGLISH | Division of Southwest Imports (DSWI) |
| 9/13/2024 | 29FGT99ENERGY DRINK CAFFEINE, CARBONATED, N.E.C. | Division of Southwest Imports (DSWI) | |
| 9/13/2024 | 29FGT99ENERGY DRINK CAFFEINE, CARBONATED, N.E.C. | Division of Southwest Imports (DSWI) | |
| 9/13/2024 | 29FGT99ENERGY DRINK CAFFEINE, CARBONATED, N.E.C. | Division of Southwest Imports (DSWI) | |
| 9/13/2024 | 21AHT99MIXED FRUIT, N.E.C. | 256INCONSPICU | Division of Southwest Imports (DSWI) |
| 9/13/2024 | 21AHT99MIXED FRUIT, N.E.C. | 256INCONSPICU | Division of Southwest Imports (DSWI) |
| 9/13/2024 | 21AHT99MIXED FRUIT, N.E.C. | 256INCONSPICU | Division of Southwest Imports (DSWI) |
| 9/13/2024 | 21AHT99MIXED FRUIT, N.E.C. | 256INCONSPICU | Division of Southwest Imports (DSWI) |
| 10/17/2023 | 29CHT99NONALCOHOLIC BEVERAGES, N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/17/2023 | 29CHT99NONALCOHOLIC BEVERAGES, N.E.C. | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is QUALMEX SA DE CV's FDA import refusal history?
QUALMEX SA DE CV (FEI: 3013728639) has 10 FDA import refusal record(s) in our database, spanning from 10/17/2023 to 6/17/2025.
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. QUALMEX SA DE CV's FEI number is 3013728639.
What types of violations has QUALMEX SA DE CV received?
QUALMEX SA DE CV 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 QUALMEX SA DE CV come from?
All FDA import refusal data for QUALMEX 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.