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LABORATORIOS SILANES S A DE C V

⚠️ Moderate Risk

FEI: 3016561120 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3016561120

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Avenida Paseo De Las Palmas No 340 Piso 3er, Col. Lomas De Chapultepec Iii Seccion, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
10/6/2022
Latest Refusal
10/6/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
20.6×20%
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
10/6/2022
61PDY55METFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS SILANES S A DE C V's FDA import refusal history?

LABORATORIOS SILANES S A DE C V (FEI: 3016561120) has 1 FDA import refusal record(s) in our database, spanning from 10/6/2022 to 10/6/2022.

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. LABORATORIOS SILANES S A DE C V's FEI number is 3016561120.

What types of violations has LABORATORIOS SILANES S A DE C V received?

LABORATORIOS SILANES S A DE C 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 LABORATORIOS SILANES S A DE C V come from?

All FDA import refusal data for LABORATORIOS SILANES S A DE C 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.