GRUPO IPENSA DE MEXICO SA DE CV
⚠️ Moderate Risk
FEI: 3030483897 • Jalisco • MEXICO
FEI Number
3030483897
Location
Jalisco
Country
MEXICOAddress
Priv Volcan Quinceo 201, , Jalisco, , 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) | |
| 3/21/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GRUPO IPENSA DE MEXICO SA DE CV's FDA import refusal history?
GRUPO IPENSA DE MEXICO SA DE CV (FEI: 3030483897) has 2 FDA import refusal record(s) in our database, spanning from 3/21/2024 to 3/21/2024.
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. GRUPO IPENSA DE MEXICO SA DE CV's FEI number is 3030483897.
What types of violations has GRUPO IPENSA DE MEXICO SA DE CV received?
GRUPO IPENSA 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 GRUPO IPENSA DE MEXICO SA DE CV come from?
All FDA import refusal data for GRUPO IPENSA 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.