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Janssen Biotech Inc.

⚠️ Moderate Risk

FEI: 3006473233 • Horsham, PA • UNITED STATES

FEI

FEI Number

3006473233

📍

Location

Horsham, PA

🇺🇸
🏢

Address

850 Ridgeview Dr, , Horsham, PA, United States

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/19/2018
Latest Refusal
3/25/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.3×10%
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
11/19/2018
66NCA04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/9/2018
61TCA31DOMPERIDONE
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/25/2016
66VIR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Janssen Biotech Inc.'s FDA import refusal history?

Janssen Biotech Inc. (FEI: 3006473233) has 3 FDA import refusal record(s) in our database, spanning from 3/25/2016 to 11/19/2018.

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 Biotech Inc.'s FEI number is 3006473233.

What types of violations has Janssen Biotech Inc. received?

Janssen Biotech Inc. 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 Biotech Inc. come from?

All FDA import refusal data for Janssen Biotech Inc. 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.