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SANOFI AVENTIS SOUTH AFRICA PTY

⚠️ Moderate Risk

FEI: 3012543690 • Midrand, Gauteng • SOUTH AFRICA

FEI

FEI Number

3012543690

📍

Location

Midrand, Gauteng

🇿🇦
🏢

Address

2 Bond Street, , Midrand, Gauteng, South Africa

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
9/14/2016
Latest Refusal
9/14/2016
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
9/14/2016
61MCA30VALPROATE SODIUM (ANTI-CONVULSANT)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is SANOFI AVENTIS SOUTH AFRICA PTY's FDA import refusal history?

SANOFI AVENTIS SOUTH AFRICA PTY (FEI: 3012543690) has 1 FDA import refusal record(s) in our database, spanning from 9/14/2016 to 9/14/2016.

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 SOUTH AFRICA PTY's FEI number is 3012543690.

What types of violations has SANOFI AVENTIS SOUTH AFRICA PTY received?

SANOFI AVENTIS SOUTH AFRICA PTY 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 SOUTH AFRICA PTY come from?

All FDA import refusal data for SANOFI AVENTIS SOUTH AFRICA PTY 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.