Janssen - Cilag Spa.
⚠️ High Risk
FEI: 3003164454 • Latina, Latina • ITALY
FEI Number
3003164454
Location
Latina, Latina
Country
ITALYAddress
Via Carlo Janssen S N, , Latina, Latina, Italy
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/25/2025 | 63HCY26PRUCALOPRIDE SUCCINATE (CATHARTIC) | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2021 | 62IIE99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2020 | 63HDY26PRUCALOPRIDE SUCCINATE (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/14/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2016 | 61WDJ07ECONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/31/2015 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 60WCY16MEBENDAZOLE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 6/6/2014 | 60WBC16MEBENDAZOLE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 1/13/2014 | 60WDF16MEBENDAZOLE (ANTHELMINTIC) | New York District Office (NYK-DO) | |
| 5/28/2013 | 60WDF16MEBENDAZOLE (ANTHELMINTIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 10/12/2012 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/4/2006 | 56OCP01LEVAQUIN (FLUOROQUINOLONE) | New York District Office (NYK-DO) | |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 9/8/2005 | 66MCB49PERPHENAZINE (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2005 | 66NCB04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | New York District Office (NYK-DO) | |
| 3/23/2005 | 60WCC16MEBENDAZOLE (ANTHELMINTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Janssen - Cilag Spa.'s FDA import refusal history?
Janssen - Cilag Spa. (FEI: 3003164454) has 18 FDA import refusal record(s) in our database, spanning from 3/23/2005 to 9/25/2025.
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 - Cilag Spa.'s FEI number is 3003164454.
What types of violations has Janssen - Cilag Spa. received?
Janssen - Cilag Spa. has been cited for 5 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 Spa. come from?
All FDA import refusal data for Janssen - Cilag Spa. 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.