Sun Pharmaceutical Industries, Ltd. - Silvassa
⚠️ High Risk
FEI: 3004076521 • Silvassa • INDIA
FEI Number
3004076521
Location
Silvassa
Country
INDIAAddress
Survey 214, Plot 20, Phase II, Government Industrial Area Road, Silvassa, , 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).
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 |
|---|---|---|---|
| 10/24/2025 | 60CDB61MIRABEGRON (ADRENERGIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 10/24/2025 | 60CDB61MIRABEGRON (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/13/2012 | 61TDB26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2011 | 61NCB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/2/2011 | 61MCB06CLONAZEPAM (ANTI-CONVULSANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/4/2011 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/8/2010 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/2/2003 | 62JIB09LEVODOPA (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries, Ltd. - Silvassa's FDA import refusal history?
Sun Pharmaceutical Industries, Ltd. - Silvassa (FEI: 3004076521) has 9 FDA import refusal record(s) in our database, spanning from 12/2/2003 to 10/24/2025.
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. Sun Pharmaceutical Industries, Ltd. - Silvassa's FEI number is 3004076521.
What types of violations has Sun Pharmaceutical Industries, Ltd. - Silvassa received?
Sun Pharmaceutical Industries, Ltd. - Silvassa has been cited for 3 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 Pharmaceutical Industries, Ltd. - Silvassa come from?
All FDA import refusal data for Sun Pharmaceutical Industries, Ltd. - Silvassa 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.