NOVO NORDISK MEXICO S.A. DE C.V.
⚠️ High Risk
FEI: 3031366844 • Miguel Hidalgo • MEXICO
FEI Number
3031366844
Location
Miguel Hidalgo
Country
MEXICOAddress
Av Homero 1500 Polanco, , 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 |
|---|---|---|---|
| 7/26/2025 | 61PCA72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2025 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 61PCY72SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NOVO NORDISK MEXICO S.A. DE C.V.'s FDA import refusal history?
NOVO NORDISK MEXICO S.A. DE C.V. (FEI: 3031366844) has 3 FDA import refusal record(s) in our database, spanning from 7/17/2024 to 7/26/2025.
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. NOVO NORDISK MEXICO S.A. DE C.V.'s FEI number is 3031366844.
What types of violations has NOVO NORDISK MEXICO S.A. DE C.V. received?
NOVO NORDISK MEXICO S.A. DE C.V. 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 NOVO NORDISK MEXICO S.A. DE C.V. come from?
All FDA import refusal data for NOVO NORDISK MEXICO S.A. DE C.V. 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.