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Janssen Pharmaceuticals

⚠️ Moderate Risk

FEI: 3007702687 • Englewood, CO • UNITED STATES

FEI

FEI Number

3007702687

📍

Location

Englewood, CO

🇺🇸
🏢

Address

9635 Maroon Cir Ste 200, , Englewood, CO, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/21/2009
Latest Refusal
8/21/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1791×

AGR RX

The article appears 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.

Refusal History

DateProductViolationsDivision
8/21/2009
61NDA82GALANTAMINE HYDROBROMIDE (ANTI-DEPRESSANT)
179AGR RX
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Janssen Pharmaceuticals's FDA import refusal history?

Janssen Pharmaceuticals (FEI: 3007702687) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 8/21/2009.

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 Pharmaceuticals's FEI number is 3007702687.

What types of violations has Janssen Pharmaceuticals received?

Janssen Pharmaceuticals 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 Pharmaceuticals come from?

All FDA import refusal data for Janssen Pharmaceuticals 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.