Sun Pharmaceutical Industries
⚠️ High Risk
FEI: 3005831271 • Mumbai, Maharashtra • INDIA
FEI Number
3005831271
Location
Mumbai, Maharashtra
Country
INDIAAddress
1st Floor, Acme Plaza, Andheri Kurla 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/2/2026 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/2/2026 | 62CCA68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2025 | 66PCY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/21/2025 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/3/2024 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/20/2024 | 62GDQ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 8/20/2024 | 62GDQ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 11/30/2023 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/10/2023 | 62GAQ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/3/2023 | 62GBQ90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/25/2022 | 60LDY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2018 | 64SCA99HYPNOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2018 | 65JDE31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2018 | 65JDE10DYDROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 61PCY55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 62GDK90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/18/2017 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2015 | 64LDY44METHYLPREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/24/2014 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/29/2013 | 61LDY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/1/2012 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/16/2012 | 61NCC74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 61PCA62PIOGLITAZONE HCL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/26/2007 | 64BDB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/18/2005 | 60LDZ65SALSALATE (ANALGESIC) | New York District Office (NYK-DO) | |
| 3/29/2005 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/24/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2003 | 65VCY56ZOLPIDEM TARTRATE (SEDATIVE) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries's FDA import refusal history?
Sun Pharmaceutical Industries (FEI: 3005831271) has 29 FDA import refusal record(s) in our database, spanning from 11/3/2003 to 1/2/2026.
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's FEI number is 3005831271.
What types of violations has Sun Pharmaceutical Industries received?
Sun Pharmaceutical Industries has been cited for 4 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 come from?
All FDA import refusal data for Sun Pharmaceutical Industries 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.