DIRECT M FRESH S.A. DE C.V.
⚠️ Moderate Risk
FEI: 3012545850 • Santa Catarina • MEXICO
FEI Number
3012545850
Location
Santa Catarina
Country
MEXICOAddress
Zimex, Dionisio de Herrera # 108; Nuevo, Santa Catarina, , 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2019 | 33JGH06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/6/2019 | 33JGH06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 12/14/2018 | 33JGH06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is DIRECT M FRESH S.A. DE C.V.'s FDA import refusal history?
DIRECT M FRESH S.A. DE C.V. (FEI: 3012545850) has 3 FDA import refusal record(s) in our database, spanning from 12/14/2018 to 8/2/2019.
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 S.A. DE C.V.'s FEI number is 3012545850.
What types of violations has DIRECT M FRESH S.A. DE C.V. received?
DIRECT M FRESH S.A. DE C.V. 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 DIRECT M FRESH S.A. DE C.V. come from?
All FDA import refusal data for DIRECT M FRESH S.A. DE C.V. 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.