BIOMEP SA DE CV
⚠️ High Risk
FEI: 3012756301 • JUAREZ • MEXICO
FEI Number
3012756301
Location
JUAREZ
Country
MEXICOAddress
URBINA NO.15 PARQUE IND, , 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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2019 | 64BCB24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2017 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/21/2017 | 62KIF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 66FCB05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/11/2017 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 11/28/2016 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 60SCA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2016 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BIOMEP SA DE CV's FDA import refusal history?
BIOMEP SA DE CV (FEI: 3012756301) has 12 FDA import refusal record(s) in our database, spanning from 10/7/2016 to 1/16/2019.
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. BIOMEP SA DE CV's FEI number is 3012756301.
What types of violations has BIOMEP SA DE CV received?
BIOMEP SA DE CV has been cited for 3 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 BIOMEP SA DE CV come from?
All FDA import refusal data for BIOMEP 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.