Janssen-Silag S.p.A.
⚠️ Moderate Risk
FEI: 3008794875 • Cologno Monzese, Milan • ITALY
FEI Number
3008794875
Location
Cologno Monzese, Milan
Country
ITALYAddress
Via Michelangelo Buonarroti 23, , Cologno Monzese, Milan, Italy
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 12/13/2011 | 61MCA40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/9/2007 | 61WCE46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/24/2005 | 61NCC99ANTI-DEPRESSANT N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Janssen-Silag S.p.A.'s FDA import refusal history?
Janssen-Silag S.p.A. (FEI: 3008794875) has 3 FDA import refusal record(s) in our database, spanning from 5/24/2005 to 12/13/2011.
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-Silag S.p.A.'s FEI number is 3008794875.
What types of violations has Janssen-Silag S.p.A. received?
Janssen-Silag S.p.A. 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-Silag S.p.A. come from?
All FDA import refusal data for Janssen-Silag S.p.A. 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.