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Sanofi Synthelabo

⚠️ Moderate Risk

FEI: 3004688903 • Guildford, Surrey • UNITED KINGDOM

FEI

FEI Number

3004688903

📍

Location

Guildford, Surrey

🇬🇧
🏢

Address

1 Onslow Road, , Guildford, Surrey, United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/22/2013
Latest Refusal
9/19/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
5.8×10%
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

753×

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
11/22/2013
62GIB99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Detroit District Office (DET-DO)
11/3/2008
61NCY37LITHIUM CARBONATE (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/19/2008
62ZCY10OXALIPLATIN
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sanofi Synthelabo's FDA import refusal history?

Sanofi Synthelabo (FEI: 3004688903) has 3 FDA import refusal record(s) in our database, spanning from 9/19/2008 to 11/22/2013.

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 Synthelabo's FEI number is 3004688903.

What types of violations has Sanofi Synthelabo received?

Sanofi Synthelabo 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 Synthelabo come from?

All FDA import refusal data for Sanofi Synthelabo 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.