BAYER DE MEXICO SA DE CV
⚠️ High Risk
FEI: 3029903225 • Mexico City • MEXICO
FEI Number
3029903225
Location
Mexico City
Country
MEXICOAddress
Miguel Angel De Cervant, , 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).
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).
Refusal History
Frequently Asked Questions
What is BAYER DE MEXICO SA DE CV's FDA import refusal history?
BAYER DE MEXICO SA DE CV (FEI: 3029903225) has 2 FDA import refusal record(s) in our database, spanning from 3/8/2024 to 10/28/2025.
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. BAYER DE MEXICO SA DE CV's FEI number is 3029903225.
What types of violations has BAYER DE MEXICO SA DE CV received?
BAYER DE MEXICO SA 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 BAYER DE MEXICO SA DE CV come from?
All FDA import refusal data for BAYER DE 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.