Janssen Biologics B.V.
⚠️ High Risk
FEI: 3002806632 • Leiden, Zuid-Holland • NETHERLANDS
FEI Number
3002806632
Location
Leiden, Zuid-Holland
Country
NETHERLANDSAddress
Einsteinweg 101, , Leiden, Zuid-Holland, Netherlands
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 60LCY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 58MCY27USTEKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/11/2024 | 62NCY09USTEKINUMAB (ANTI-PSORIATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/19/2021 | 62NAA09USTEKINUMAB (ANTI-PSORIATIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/28/2020 | 64OIY99MONOCLONAL ANTIBODIES, N.E.C. | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Janssen Biologics B.V.'s FDA import refusal history?
Janssen Biologics B.V. (FEI: 3002806632) has 6 FDA import refusal record(s) in our database, spanning from 2/28/2020 to 11/17/2025.
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 Biologics B.V.'s FEI number is 3002806632.
What types of violations has Janssen Biologics B.V. received?
Janssen Biologics B.V. 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 Biologics B.V. come from?
All FDA import refusal data for Janssen Biologics B.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.