Sun Pharmaceuticals Industries Ltd
⚠️ High Risk
FEI: 3011602579 • Mumbai, Maharashtra • INDIA
FEI Number
3011602579
Location
Mumbai, Maharashtra
Country
INDIAAddress
1 Sun House, Cts No 1498 A/2 Mv Road; Cts No 201, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2024 | 60YCY99INHIBITOR (GROWTH FACTOR) N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 61MDB06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2022 | 56BDY49SODIUM OXACILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2021 | 56KCS85VANCOMYCIN HYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2021 | 61WCO99A-FUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 61MCY35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 61MCY35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 61MDY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/4/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 61PDA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 64JCA99GAS, MEDICINAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2018 | 56ECY60MINOCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2017 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 54ABB12FOLIC ACID (VITAMIN) | Division of Southeast Imports (DSEI) | |
| 10/12/2017 | 61NDB73MIRTAZAPINE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 9/18/2017 | 61TCY26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2017 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2016 | 56BCH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New Orleans District Office (NOL-DO) | |
| 10/7/2016 | 61JCB09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/7/2016 | 60XCB02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/30/2016 | 66NDA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sun Pharmaceuticals Industries Ltd's FDA import refusal history?
Sun Pharmaceuticals Industries Ltd (FEI: 3011602579) has 24 FDA import refusal record(s) in our database, spanning from 9/30/2016 to 9/4/2024.
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. Sun Pharmaceuticals Industries Ltd's FEI number is 3011602579.
What types of violations has Sun Pharmaceuticals Industries Ltd received?
Sun Pharmaceuticals Industries Ltd 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 Sun Pharmaceuticals Industries Ltd come from?
All FDA import refusal data for Sun Pharmaceuticals Industries Ltd 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.