MEXICANA SA DE CV
⚠️ High Risk
FEI: 3012720517 • Miguel Hidalgo • MEXICO
FEI Number
3012720517
Location
Miguel Hidalgo
Country
MEXICOAddress
Cueducto NO. 15, Col. RE, Miguel Hidalgo, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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 |
|---|---|---|---|
| 11/4/2024 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2022 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/17/2021 | 61ECY14KETOTIFEN FUMERATE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEXICANA SA DE CV's FDA import refusal history?
MEXICANA SA DE CV (FEI: 3012720517) has 3 FDA import refusal record(s) in our database, spanning from 11/17/2021 to 11/4/2024.
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. MEXICANA SA DE CV's FEI number is 3012720517.
What types of violations has MEXICANA SA DE CV received?
MEXICANA SA DE CV has been cited for 1 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 MEXICANA SA DE CV come from?
All FDA import refusal data for MEXICANA 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.