ImportRefusal LogoImportRefusal

Sanofi-Aventis US LLC

⚠️ High Risk

FEI: 1000117606 • Saint Louis, MO • UNITED STATES

FEI

FEI Number

1000117606

📍

Location

Saint Louis, MO

🇺🇸
🏢

Address

6244 Lemay Ferry Rd, , Saint Louis, MO, United States

High Risk

FDA Import Risk Assessment

70.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

222
Total Refusals
4
Unique Violations
1/30/2017
Latest Refusal
2/23/2015
Earliest Refusal

Score Breakdown

Violation Severity
85.8×40%
Refusal Volume
87.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

75196×

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).

11820×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

38756×

708REIMPRT

The article has been determined to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/30/2017
60LBK99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sanofi-Aventis US LLC's FDA import refusal history?

Sanofi-Aventis US LLC (FEI: 1000117606) has 222 FDA import refusal record(s) in our database, spanning from 2/23/2015 to 1/30/2017.

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 US LLC's FEI number is 1000117606.

What types of violations has Sanofi-Aventis US LLC received?

Sanofi-Aventis US LLC has been cited for 4 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 US LLC come from?

All FDA import refusal data for Sanofi-Aventis US LLC 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.