Janssen Cilag Ltd
⚠️ Moderate Risk
FEI: 3002348847 • High Wycombe, Buckinghamshire • UNITED KINGDOM
FEI Number
3002348847
Location
High Wycombe, Buckinghamshire
Country
UNITED KINGDOMAddress
Saunderton, , High Wycombe, Buckinghamshire, United Kingdom
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2011 | 64LBO37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2008 | 66NCY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/25/2006 | 65JIA27NORGESTIMATE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Janssen Cilag Ltd's FDA import refusal history?
Janssen Cilag Ltd (FEI: 3002348847) has 3 FDA import refusal record(s) in our database, spanning from 5/25/2006 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 Cilag Ltd's FEI number is 3002348847.
What types of violations has Janssen Cilag Ltd received?
Janssen Cilag Ltd has been cited for 1 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 Ltd come from?
All FDA import refusal data for Janssen Cilag Ltd 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.