ImportRefusal LogoImportRefusal

Sanofi-Pasteur

⚠️ Moderate Risk

FEI: 3009954718 • Chicago, IL • UNITED STATES

FEI

FEI Number

3009954718

📍

Location

Chicago, IL

🇺🇸
🏢

Address

12458 Collections Ctr Dr, , Chicago, IL, United States

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
2/14/2013
Latest Refusal
2/14/2013
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

1851×

REDUCED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.

Refusal History

DateProductViolationsDivision
2/14/2013
57HH38TYPHOID VACCINE
185REDUCED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sanofi-Pasteur's FDA import refusal history?

Sanofi-Pasteur (FEI: 3009954718) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2013 to 2/14/2013.

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-Pasteur's FEI number is 3009954718.

What types of violations has Sanofi-Pasteur received?

Sanofi-Pasteur 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-Pasteur come from?

All FDA import refusal data for Sanofi-Pasteur 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.