Janssen Cilag
⚠️ High Risk
FEI: 3002911403 • Issy Les Moulineax • FRANCE
FEI Number
3002911403
Location
Issy Les Moulineax
Country
FRANCEAddress
1 Rue Camille Desmoulins, , Issy Les Moulineax, , France
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2024 | 60WCB16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/3/2021 | 60SCY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2016 | 61TDK31DOMPERIDONE | Division of Southeast Imports (DSEI) | |
| 8/21/2008 | 62GCB41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/6/2007 | 66MBP75BROMAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2005 | 61NCY82GALANTAMINE HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Janssen Cilag's FDA import refusal history?
Janssen Cilag (FEI: 3002911403) has 6 FDA import refusal record(s) in our database, spanning from 7/20/2005 to 6/24/2024.
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 Cilag's FEI number is 3002911403.
What types of violations has Janssen Cilag received?
Janssen Cilag has been cited for 2 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 Cilag come from?
All FDA import refusal data for Janssen Cilag 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.