HELTHE BRANDS DE MEXICO SA DE CV
⚠️ Moderate Risk
FEI: 3014265005 • San Nicolas De Los Ga • MEXICO
FEI Number
3014265005
Location
San Nicolas De Los Ga
Country
MEXICOAddress
Adolfo Lopez Mateos 290-4, , San Nicolas De Los Ga, , 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
JUICE %
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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
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
Frequently Asked Questions
What is HELTHE BRANDS DE MEXICO SA DE CV's FDA import refusal history?
HELTHE BRANDS DE MEXICO SA DE CV (FEI: 3014265005) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2019 to 3/7/2019.
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. HELTHE BRANDS DE MEXICO SA DE CV's FEI number is 3014265005.
What types of violations has HELTHE BRANDS DE MEXICO SA DE CV received?
HELTHE BRANDS DE MEXICO SA DE CV has been cited for 2 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 HELTHE BRANDS DE MEXICO SA DE CV come from?
All FDA import refusal data for HELTHE BRANDS 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.