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FARMACIAS DE SIMILARES SA DE CV

⚠️ High Risk

FEI: 3027693007 • Mexico City • MEXICO

FEI

FEI Number

3027693007

📍

Location

Mexico City

🇲🇽

Country

MEXICO
🏢

Address

Grupo Por Un Pais Mejor, , Mexico City, , Mexico

High Risk

FDA Import Risk Assessment

50.9
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
9/15/2023
Latest Refusal
9/15/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
53.0×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
9/15/2023
62GCY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FARMACIAS DE SIMILARES SA DE CV's FDA import refusal history?

FARMACIAS DE SIMILARES SA DE CV (FEI: 3027693007) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2023 to 9/15/2023.

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 SA DE CV's FEI number is 3027693007.

What types of violations has FARMACIAS DE SIMILARES SA DE CV received?

FARMACIAS DE SIMILARES SA DE CV 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 SA DE CV come from?

All FDA import refusal data for FARMACIAS DE SIMILARES 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.