NOVO NORDISK MEXICO S.A. DE C.V.
⚠️ High Risk
FEI: 3029277585 • Tlalnepantla De Baz • MEXICO
FEI Number
3029277585
Location
Tlalnepantla De Baz
Country
MEXICOAddress
Carretera Lago De Guadl, , Tlalnepantla De Baz, , 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 |
|---|---|---|---|
| 11/16/2023 | 61PAY72SEMAGLUTIDE (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: 3029277585) has 1 FDA import refusal record(s) in our database, spanning from 11/16/2023 to 11/16/2023.
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 3029277585.
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.