FARMACOS CONTINENTALES
⚠️ High Risk
FEI: 3013260857 • Puebla • MEXICO
FEI Number
3013260857
Location
Puebla
Country
MEXICOAddress
Av San Agnacio NO 1831, , Puebla, , 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 |
|---|---|---|---|
| 3/6/2025 | 60WDB01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 60ZDY02ALBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2024 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/11/2022 | 60WDA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2021 | 60WDL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2021 | 60WDL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2021 | 65BCY99MUCOLYTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2017 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FARMACOS CONTINENTALES's FDA import refusal history?
FARMACOS CONTINENTALES (FEI: 3013260857) has 10 FDA import refusal record(s) in our database, spanning from 11/7/2017 to 3/6/2025.
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. FARMACOS CONTINENTALES's FEI number is 3013260857.
What types of violations has FARMACOS CONTINENTALES received?
FARMACOS CONTINENTALES 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 FARMACOS CONTINENTALES come from?
All FDA import refusal data for FARMACOS CONTINENTALES 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.