Janssen Pharmaceuticals, Inc
⚠️ High Risk
FEI: 2242843 • Titusville, NJ • UNITED STATES
FEI Number
2242843
Location
Titusville, NJ
Country
UNITED STATESAddress
1125 Trenton Harbourton Rd, , Titusville, NJ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2025 | 58MCK27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58MDY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58MDY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58MDY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 62NCL99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58MDY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2025 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 62NCL99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 61LCY42RIVAROXABAN | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/2/2021 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2019 | 61WDY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 61YCP01INFLIXIMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 11/13/2014 | 61MCB40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2005 | 66NCB04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Janssen Pharmaceuticals, Inc's FDA import refusal history?
Janssen Pharmaceuticals, Inc (FEI: 2242843) has 22 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 3/7/2025.
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, Inc's FEI number is 2242843.
What types of violations has Janssen Pharmaceuticals, Inc received?
Janssen Pharmaceuticals, Inc has been cited for 3 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, Inc come from?
All FDA import refusal data for Janssen Pharmaceuticals, 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.