Bioresearch De Mexico Sa
⚠️ High Risk
FEI: 3007180551 • De Juarez • MEXICO
FEI Number
3007180551
Location
De Juarez
Country
MEXICOAddress
Avenida Rio Totolica No 15-4, , De Juarez, , 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 |
|---|---|---|---|
| 5/28/2025 | 60XCB02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 64BDY37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2016 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/23/2016 | 61PCA68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/15/2012 | 62VCS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/15/2012 | 64BCA37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bioresearch De Mexico Sa's FDA import refusal history?
Bioresearch De Mexico Sa (FEI: 3007180551) has 6 FDA import refusal record(s) in our database, spanning from 6/15/2012 to 5/28/2025.
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. Bioresearch De Mexico Sa's FEI number is 3007180551.
What types of violations has Bioresearch De Mexico Sa received?
Bioresearch De Mexico Sa 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 Bioresearch De Mexico Sa come from?
All FDA import refusal data for Bioresearch De Mexico Sa 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.