Lupin Pharmaceuticals Inc.
⚠️ High Risk
FEI: 3004097115 • Naples, FL • UNITED STATES
FEI Number
3004097115
Location
Naples, FL
Country
UNITED STATESAddress
5801 Pelican Bay Blvd, Suite 500, Naples, FL, 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
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).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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 |
|---|---|---|---|
| 2/7/2025 | 64GDY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2022 | 62CDB65LISINOPRIL (ANTI-HYPERTENSIVE) | 3340DE/RX KIT | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 61NCY78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 64BDA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 62CDA62DESERPEDINE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2015 | 62OIY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Lupin Pharmaceuticals Inc.'s FDA import refusal history?
Lupin Pharmaceuticals Inc. (FEI: 3004097115) has 6 FDA import refusal record(s) in our database, spanning from 12/4/2015 to 2/7/2025.
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. Lupin Pharmaceuticals Inc.'s FEI number is 3004097115.
What types of violations has Lupin Pharmaceuticals Inc. received?
Lupin Pharmaceuticals Inc. 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 Lupin Pharmaceuticals Inc. come from?
All FDA import refusal data for Lupin Pharmaceuticals 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.