Janssen Inc.
🚨 Critical Risk
FEI: 3002594622 • North York, Ontario • CANADA
FEI Number
3002594622
Location
North York, Ontario
Country
CANADAAddress
19 Green Belt Dr, , North York, Ontario, Canada
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2025 | 61NCY05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 61NCY05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 63HCB26PRUCALOPRIDE SUCCINATE (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2025 | 66NCY10PALIPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2025 | 58MCL27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/6/2025 | 62VCA59ETRAVIRINE (ANTI-VIRAL) | Division of Northern Border Imports (DNBI) | |
| 3/20/2025 | 58ODY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 62QDY99ANTI-RHEUMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2025 | 58ODY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 62GDL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 62GDL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58ODY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2025 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 64QDY99HISTIDINE DECARBOXYLASE INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 58SCY16GOLIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 58SCY16GOLIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2025 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2024 | 58OCY06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2024 | 58SCK16GOLIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/28/2024 | 58OCL06GUSELKUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2024 | 61PCA69CANAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2024 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2024 | 60WDY16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/10/2020 | 56HDK24DOXORUBICIN HYDROCHLORIDE (ANTITUMOR) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 61PCY69CANAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2018 | 64GCB27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2017 | 66BDB19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2017 | 65JDA27NORGESTIMATE (PROGESTIN) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/22/2017 | 64GDC07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/21/2016 | 66VDE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2016 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/5/2012 | 65JDA27NORGESTIMATE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 60SDA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 60SDA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/15/2011 | 66QDB10PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/5/2010 | 66BDA19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/14/2009 | 65JCY27NORGESTIMATE (PROGESTIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2009 | 65JCA27NORGESTIMATE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/24/2008 | 61NDA37LITHIUM CARBONATE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/22/2008 | 61GCY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/3/2008 | 60SCH21CISAPRIDE (ANTACID) | Detroit District Office (DET-DO) | |
| 9/20/2006 | 62UCA08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2006 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 342PERSONALRX | New York District Office (NYK-DO) |
| 10/12/2005 | 60SCI21CISAPRIDE (ANTACID) | Detroit District Office (DET-DO) | |
| 3/29/2005 | 61MCY40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/5/2004 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/4/2004 | 64UDA99INHIBITOR N.E.C. | Detroit District Office (DET-DO) | |
| 3/14/2003 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Janssen Inc.'s FDA import refusal history?
Janssen Inc. (FEI: 3002594622) has 62 FDA import refusal record(s) in our database, spanning from 3/14/2003 to 12/19/2025.
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 Inc.'s FEI number is 3002594622.
What types of violations has Janssen Inc. received?
Janssen Inc. 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 Janssen Inc. come from?
All FDA import refusal data for Janssen 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.