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Sanofi Aventia

⚠️ Moderate Risk

FEI: 3005374223 • Surrey • UNITED KINGDOM

FEI

FEI Number

3005374223

📍

Location

Surrey

🇬🇧
🏢

Address

Unknown Street, , Surrey, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
7/31/2014
Latest Refusal
6/18/2008
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
8.2×10%
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

755×

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).

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
7/31/2014
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/29/2013
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/18/2008
60SCA23METOCLOPRAMIDE (ANTACID)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/18/2008
61TCA12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
6/18/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Sanofi Aventia's FDA import refusal history?

Sanofi Aventia (FEI: 3005374223) has 5 FDA import refusal record(s) in our database, spanning from 6/18/2008 to 7/31/2014.

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 Aventia's FEI number is 3005374223.

What types of violations has Sanofi Aventia received?

Sanofi Aventia has been cited for 2 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 Aventia come from?

All FDA import refusal data for Sanofi Aventia 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.