GRUNENTHAL DE MEXICO S A DE CV
⚠️ High Risk
FEI: 3013679165 • Tlalpan • MEXICO
FEI Number
3013679165
Location
Tlalpan
Country
MEXICOAddress
Periferico Sur No 5991, , Tlalpan, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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
Frequently Asked Questions
What is GRUNENTHAL DE MEXICO S A DE CV's FDA import refusal history?
GRUNENTHAL DE MEXICO S A DE CV (FEI: 3013679165) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2025 to 1/21/2026.
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. GRUNENTHAL DE MEXICO S A DE CV's FEI number is 3013679165.
What types of violations has GRUNENTHAL DE MEXICO S A DE CV received?
GRUNENTHAL DE MEXICO S A DE CV has been cited for 2 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 GRUNENTHAL DE MEXICO S A DE CV come from?
All FDA import refusal data for GRUNENTHAL DE MEXICO S A 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.