Sun Pharmaceuticals Industries Limited
⚠️ High Risk
FEI: 3005775304 • Mumbai, Maharashtra • INDIA
FEI Number
3005775304
Location
Mumbai, Maharashtra
Country
INDIAAddress
17 B Mahakali Caves 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2024 | 65QDB99RELAXANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2016 | 56IDY10ERYTHROMYCIN (MACROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/25/2011 | 66MCA99TRANQUILIZER N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sun Pharmaceuticals Industries Limited's FDA import refusal history?
Sun Pharmaceuticals Industries Limited (FEI: 3005775304) has 4 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 7/23/2024.
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 Limited's FEI number is 3005775304.
What types of violations has Sun Pharmaceuticals Industries Limited received?
Sun Pharmaceuticals Industries Limited 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 Limited come from?
All FDA import refusal data for Sun Pharmaceuticals Industries 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.