Direct M. Fresh SA de CV
⚠️ Moderate Risk
FEI: 3013242112 • Santa Catarina, Nuevo Leon • MEXICO
FEI Number
3013242112
Location
Santa Catarina, Nuevo Leon
Country
MEXICOAddress
Privada Las Huertas 919, Residencial El Castillo, Santa Catarina, Nuevo Leon, 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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
SULFITELBL
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/13/2018 | 21XGH05MANGO (SUBTROPICAL/TROPICAL FRUIT PULP) | Division of Southwest Imports (DSWI) | |
| 7/30/2013 | 21TGH05MANGO, DRIED OR PASTE | Southwest Import District Office (SWI-DO) | |
| 4/19/2013 | 27YGT06PEPPER SAUCE (HOT, MILD, ETC.) | Southwest Import District Office (SWI-DO) | |
| 4/19/2013 | 21TGH05MANGO, DRIED OR PASTE | Southwest Import District Office (SWI-DO) | |
| 1/30/2013 | 54JYR05ROSELLE (HERBAL & BOTANICALS II) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Direct M. Fresh SA de CV's FDA import refusal history?
Direct M. Fresh SA de CV (FEI: 3013242112) has 5 FDA import refusal record(s) in our database, spanning from 1/30/2013 to 7/13/2018.
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. Direct M. Fresh SA de CV's FEI number is 3013242112.
What types of violations has Direct M. Fresh SA de CV received?
Direct M. Fresh SA de CV has been cited for 10 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 Direct M. Fresh SA de CV come from?
All FDA import refusal data for Direct M. Fresh 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.