FARMACIAS DE SIMILARES, S.A. DEC.V
⚠️ High Risk
FEI: 3014699102 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3014699102
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Alemania No. 10, Col. Independencia, Benito Juarez, Ciudad De Mexico, Ciudad de Mexico, 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 |
|---|---|---|---|
| 8/4/2024 | 62UCS20DEXTROMETHORPHAN POLISTIREX (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2019 | 60ZAA02ALBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2019 | 60ZAL02ALBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2019 | 60LAC01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FARMACIAS DE SIMILARES, S.A. DEC.V's FDA import refusal history?
FARMACIAS DE SIMILARES, S.A. DEC.V (FEI: 3014699102) has 4 FDA import refusal record(s) in our database, spanning from 3/1/2019 to 8/4/2024.
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. FARMACIAS DE SIMILARES, S.A. DEC.V's FEI number is 3014699102.
What types of violations has FARMACIAS DE SIMILARES, S.A. DEC.V received?
FARMACIAS DE SIMILARES, S.A. DEC.V 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 FARMACIAS DE SIMILARES, S.A. DEC.V come from?
All FDA import refusal data for FARMACIAS DE SIMILARES, S.A. DEC.V 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.