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LABORATORIOS SILANES SA DE CV

⚠️ Moderate Risk

FEI: 3015277612 • Tolucalco • MEXICO

FEI

FEI Number

3015277612

📍

Location

Tolucalco

🇲🇽

Country

MEXICO
🏢

Address

Eje 3 Norte Esq Prol 6, , Tolucalco, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/28/2019
Latest Refusal
6/28/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
6/28/2019
61CCL99ANTI-ANEMIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS SILANES SA DE CV's FDA import refusal history?

LABORATORIOS SILANES SA DE CV (FEI: 3015277612) has 1 FDA import refusal record(s) in our database, spanning from 6/28/2019 to 6/28/2019.

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. LABORATORIOS SILANES SA DE CV's FEI number is 3015277612.

What types of violations has LABORATORIOS SILANES SA DE CV received?

LABORATORIOS SILANES 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 LABORATORIOS SILANES SA DE CV come from?

All FDA import refusal data for LABORATORIOS SILANES 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.