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Sanofi Aventis Australia Pty Ltd

⚠️ Moderate Risk

FEI: 3009022573 • Macquarie Park, New South Wales • AUSTRALIA

FEI

FEI Number

3009022573

📍

Location

Macquarie Park, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

12-24 Talavera Rd, BLDG DTALAVERA, Macquarie Park, New South Wales, Australia

Moderate Risk

FDA Import Risk Assessment

44.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/17/2022
Latest Refusal
10/17/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
21.3×20%
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
10/17/2022
62LCY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sanofi Aventis Australia Pty Ltd's FDA import refusal history?

Sanofi Aventis Australia Pty Ltd (FEI: 3009022573) has 1 FDA import refusal record(s) in our database, spanning from 10/17/2022 to 10/17/2022.

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. Sanofi Aventis Australia Pty Ltd's FEI number is 3009022573.

What types of violations has Sanofi Aventis Australia Pty Ltd received?

Sanofi Aventis Australia Pty Ltd 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 Aventis Australia Pty Ltd come from?

All FDA import refusal data for Sanofi Aventis Australia Pty Ltd 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.