Sun Pharmaceutical Industries Limited
⚠️ High Risk
FEI: 3002871444 • Gurugram, Haryana • INDIA
FEI Number
3002871444
Location
Gurugram, Haryana
Country
INDIAAddress
Sarhaul, Sector-18, , Gurugram, Haryana, 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2023 | 60LDY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 61TDF31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/20/2015 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 12/6/2011 | 62ODA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/1/2001 | 61FCB55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries Limited's FDA import refusal history?
Sun Pharmaceutical Industries Limited (FEI: 3002871444) has 6 FDA import refusal record(s) in our database, spanning from 11/1/2001 to 1/3/2023.
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 3002871444.
What types of violations has Sun Pharmaceutical Industries Limited received?
Sun Pharmaceutical Industries Limited 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 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.