BAYER DE MEXICO SA DE
⚠️ High Risk
FEI: 3016860358 • Lerma • 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2024 | 62UDA20DEXTROMETHORPHAN POLISTIREX (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 64LCA03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2023 | 60LCB99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/18/2023 | 60LCB99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BAYER DE MEXICO SA DE's FDA import refusal history?
BAYER DE MEXICO SA DE (FEI: 3016860358) has 7 FDA import refusal record(s) in our database, spanning from 10/18/2023 to 2/27/2025.
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's FEI number is 3016860358.
What types of violations has BAYER DE MEXICO SA DE received?
BAYER DE MEXICO SA DE 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 come from?
All FDA import refusal data for BAYER DE MEXICO SA DE 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.