Sun Pharmaceutical Industries Limited
⚠️ Moderate Risk
FEI: 3003227153 • Ahmednagar, Maharashtra • INDIA
FEI Number
3003227153
Location
Ahmednagar, Maharashtra
Country
INDIAAddress
A-7 & A-8 Midc Industrial Area, , Ahmednagar, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2019 | 62TCY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2013 | 62GCT92FLURBIPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 4/10/2013 | 62GCT92FLURBIPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 4/10/2013 | 62GCT92FLURBIPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 4/10/2013 | 62GCT92FLURBIPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 4/10/2013 | 62GCT92FLURBIPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 4/10/2013 | 62GCT92FLURBIPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 12/23/2009 | 66SCA03BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries Limited's FDA import refusal history?
Sun Pharmaceutical Industries Limited (FEI: 3003227153) has 8 FDA import refusal record(s) in our database, spanning from 12/23/2009 to 12/11/2019.
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 Limited's FEI number is 3003227153.
What types of violations has Sun Pharmaceutical Industries Limited received?
Sun Pharmaceutical 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 Pharmaceutical Industries Limited come from?
All FDA import refusal data for Sun Pharmaceutical 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.