Janssen Ortho LLC
⚠️ Moderate Risk
FEI: 3002942061 • Gurabo, PR • UNITED STATES
FEI Number
3002942061
Location
Gurabo, PR
Country
UNITED STATESAddress
State Road 933 Km 0.1,Mamey Ward, , Gurabo, PR, United States
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2021 | 61MDY40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2016 | 66BDA19METHYLPHENIDATE HCL (STIMULANT) | 179AGR RX | Florida District Office (FLA-DO) |
| 3/15/2016 | 62VIA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2010 | 61MCA40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/31/2010 | 66QDY10PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 179AGR RX | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Janssen Ortho LLC's FDA import refusal history?
Janssen Ortho LLC (FEI: 3002942061) has 5 FDA import refusal record(s) in our database, spanning from 8/31/2010 to 10/25/2021.
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 Ortho LLC's FEI number is 3002942061.
What types of violations has Janssen Ortho LLC received?
Janssen Ortho LLC 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 Ortho LLC come from?
All FDA import refusal data for Janssen Ortho LLC 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.