EXELTIS PHARMA MEXICO SA DE CV
⚠️ High Risk
FEI: 3021173860 • Tultitlan • MEXICO
FEI Number
3021173860
Location
Tultitlan
Country
MEXICOAddress
Calle Olivo S/N Int 16, , Tultitlan, , 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 |
|---|---|---|---|
| 5/27/2025 | 54AFA12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2025 | 54AFA12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2024 | 54YFH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EXELTIS PHARMA MEXICO SA DE CV's FDA import refusal history?
EXELTIS PHARMA MEXICO SA DE CV (FEI: 3021173860) has 3 FDA import refusal record(s) in our database, spanning from 11/14/2024 to 5/27/2025.
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. EXELTIS PHARMA MEXICO SA DE CV's FEI number is 3021173860.
What types of violations has EXELTIS PHARMA MEXICO SA DE CV received?
EXELTIS PHARMA MEXICO 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 EXELTIS PHARMA MEXICO SA DE CV come from?
All FDA import refusal data for EXELTIS PHARMA 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.