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Janssen Litag

⚠️ Moderate Risk

FEI: 3004204531 • Berchem, Antwerp • BELGIUM

FEI

FEI Number

3004204531

📍

Location

Berchem, Antwerp

🇧🇪

Country

BELGIUM
🏢

Address

Roderveldlaan 1, , Berchem, Antwerp, Belgium

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/28/2009
Latest Refusal
2/2/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
7.0×10%
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

754×

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
10/28/2009
61TCA99ANTI-EMETIC/NAUSEANT N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/1/2004
66VCB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
2/3/2004
60MCP06CODEINE SULFATE (ANALGESIC, NARCOTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/2/2004
61TCA99ANTI-EMETIC/NAUSEANT N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Janssen Litag's FDA import refusal history?

Janssen Litag (FEI: 3004204531) has 4 FDA import refusal record(s) in our database, spanning from 2/2/2004 to 10/28/2009.

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. Janssen Litag's FEI number is 3004204531.

What types of violations has Janssen Litag received?

Janssen Litag 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 Janssen Litag come from?

All FDA import refusal data for Janssen Litag 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.