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SANOFI ILAC SANAYI VE TICARET ANONI

⚠️ High Risk

FEI: 3038988381 • Luleburgaz, Kirklareli • TURKEY

FEI

FEI Number

3038988381

📍

Location

Luleburgaz, Kirklareli

🇹🇷

Country

TURKEY
🏢

Address

Kucukkaristiran Mahallesi, Merkez Kume Evleri No 223/A, Luleburgaz, Kirklareli, Turkey

High Risk

FDA Import Risk Assessment

59.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/20/2025
Latest Refusal
10/20/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
95.4×20%
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
10/20/2025
61LAB42RIVAROXABAN
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SANOFI ILAC SANAYI VE TICARET ANONI's FDA import refusal history?

SANOFI ILAC SANAYI VE TICARET ANONI (FEI: 3038988381) has 1 FDA import refusal record(s) in our database, spanning from 10/20/2025 to 10/20/2025.

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. SANOFI ILAC SANAYI VE TICARET ANONI's FEI number is 3038988381.

What types of violations has SANOFI ILAC SANAYI VE TICARET ANONI received?

SANOFI ILAC SANAYI VE TICARET ANONI 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 SANOFI ILAC SANAYI VE TICARET ANONI come from?

All FDA import refusal data for SANOFI ILAC SANAYI VE TICARET ANONI 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.