EXELTIS PHARMA MEXICO S.A. DE C.
⚠️ High Risk
FEI: 3041357110 • Mexico City • MEXICO
FEI Number
3041357110
Location
Mexico City
Country
MEXICOAddress
Adolfo Lopez Mateos Bou, , Mexico City, , 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 |
|---|---|---|---|
| 1/13/2026 | 54YGA99VITAMIN, 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 S.A. DE C.'s FDA import refusal history?
EXELTIS PHARMA MEXICO S.A. DE C. (FEI: 3041357110) has 1 FDA import refusal record(s) in our database, spanning from 1/13/2026 to 1/13/2026.
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 S.A. DE C.'s FEI number is 3041357110.
What types of violations has EXELTIS PHARMA MEXICO S.A. DE C. received?
EXELTIS PHARMA MEXICO S.A. DE C. 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 S.A. DE C. come from?
All FDA import refusal data for EXELTIS PHARMA MEXICO S.A. DE C. 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.