Lupin Limited
⚠️ High Risk
FEI: 3004529241 • Mumbai, Maharashtra • INDIA
FEI Number
3004529241
Location
Mumbai, Maharashtra
Country
INDIAAddress
159 C S T Road, , Mumbai, Maharashtra, India
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2024 | 61JDY15EZETIMIBE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2022 | 65PDA99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 63BCQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2016 | 61NDW83ESCITALOPRAM OXALATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2015 | 61ECY06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/14/2015 | 64BDY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/14/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/25/2014 | 89MOZACID, HYALURONIC, INTRAARTICULAR | Cincinnati District Office (CIN-DO) | |
| 6/11/2012 | 61LCB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/17/2012 | 62KCA11NITAZOXANIDE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2010 | 56KCY70RIFAMPIN | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lupin Limited's FDA import refusal history?
Lupin Limited (FEI: 3004529241) has 13 FDA import refusal record(s) in our database, spanning from 7/22/2010 to 3/22/2024.
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 Limited's FEI number is 3004529241.
What types of violations has Lupin Limited received?
Lupin Limited has been cited for 4 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 Limited come from?
All FDA import refusal data for Lupin Limited 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.