Janssen Biotech, Inc.
⚠️ High Risk
FEI: 3001610451 • Malvern, PA • UNITED STATES
FEI Number
3001610451
Location
Malvern, PA
Country
UNITED STATESAddress
200 Great Valley Pkwy, , Malvern, PA, United States
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
Frequently Asked Questions
What is Janssen Biotech, Inc.'s FDA import refusal history?
Janssen Biotech, Inc. (FEI: 3001610451) has 2 FDA import refusal record(s) in our database, spanning from 11/3/2025 to 11/3/2025.
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 Biotech, Inc.'s FEI number is 3001610451.
What types of violations has Janssen Biotech, Inc. received?
Janssen Biotech, Inc. 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 Biotech, Inc. come from?
All FDA import refusal data for Janssen Biotech, Inc. 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.