Janssen Pharmaceutica, N.V.
⚠️ High Risk
FEI: 3002807336 • Beerse, Antwerp • BELGIUM
FEI Number
3002807336
Location
Beerse, Antwerp
Country
BELGIUMAddress
Turnhoutseweg 30, , Beerse, Antwerp, Belgium
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2025 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/16/2024 | 66NCL10PALIPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2022 | 66NDY10PALIPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 61WDL99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/29/2022 | 61WDL99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/12/2022 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2021 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2018 | 61BCA99ANTI-ANDROGEN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2018 | 61WDY47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 61WCY18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2018 | 61XDB09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2016 | 61XBY09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/1/2015 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/9/2015 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/29/2013 | 61BCA99ANTI-ANDROGEN, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/20/2013 | 60WDF16MEBENDAZOLE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 8/27/2012 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/3/2012 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 1/12/2012 | 61TCA31DOMPERIDONE | 472NO ENGLISH | New York District Office (NYK-DO) |
| 11/23/2011 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/28/2011 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/22/2011 | 61XCA09CINNARIZINE (ANTI-HISTAMINIC) | New Orleans District Office (NOL-DO) | |
| 9/28/2010 | 61TAY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/15/2010 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/15/2010 | 60WCK16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/6/2007 | 60LIK99ANALGESIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/21/2006 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/20/2004 | 61VCA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Janssen Pharmaceutica, N.V.'s FDA import refusal history?
Janssen Pharmaceutica, N.V. (FEI: 3002807336) has 30 FDA import refusal record(s) in our database, spanning from 1/30/2004 to 11/18/2025.
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 Pharmaceutica, N.V.'s FEI number is 3002807336.
What types of violations has Janssen Pharmaceutica, N.V. received?
Janssen Pharmaceutica, N.V. has been cited for 7 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 Pharmaceutica, N.V. come from?
All FDA import refusal data for Janssen Pharmaceutica, N.V. 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.