Sun Pharmaceutical Industries, Inc.
⚠️ Moderate Risk
FEI: 3002807972 • Punjab • INDIA
FEI Number
3002807972
Location
Punjab
Country
INDIAAddress
Village Toansa, PO Rail Majra, District Nawanshahar, Punjab, , 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).
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 |
|---|---|---|---|
| 8/25/2014 | 62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/25/2014 | 62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/23/2012 | 61NCB82GALANTAMINE HYDROBROMIDE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 1/5/2005 | 61EAS08LORATADINE (ANTI-ASTHMATIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries, Inc.'s FDA import refusal history?
Sun Pharmaceutical Industries, Inc. (FEI: 3002807972) has 4 FDA import refusal record(s) in our database, spanning from 1/5/2005 to 8/25/2014.
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, Inc.'s FEI number is 3002807972.
What types of violations has Sun Pharmaceutical Industries, Inc. received?
Sun Pharmaceutical Industries, Inc. 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, Inc. come from?
All FDA import refusal data for Sun Pharmaceutical Industries, Inc. 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.