Sun Pharmaceutical Industries Ltd.
🚨 Critical Risk
FEI: 3002809586 • Halol, Gujarat • INDIA
FEI
FEI Number
3002809586
📍
Location
Halol, Gujarat
🇮🇳
Country
INDIA🏢
Address
Halol - Baroda Highway, , Halol, Gujarat, India
Critical Risk
FDA Import Risk Assessment
81.9
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
117
Total Refusals
3
Unique Violations
11/25/2025
Latest Refusal
9/3/2009
Earliest Refusal
Score Breakdown
Violation Severity
80.5×40%
Refusal Volume
76.7×30%
Recency
97.5×20%
Frequency
72.0×10%
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
27108×
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).
7521×
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).
1185×
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 |
|---|---|---|---|
| 11/25/2025 | 62HDY02TOBRAMYCIN (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 11/25/2025 | 64DDY01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | Division of Southeast Imports (DSEI) | |
| 8/13/2025 | 62ICA99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2025 | 62OCY43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 61EBY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 60LCA99ANALGESIC, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/5/2025 | 60XDY23TIMOLOL MALEATE (ANTI-ADRENERGIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/4/2025 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 60CDB99ADRENERGIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2025 | 61ECE04BUDESONIDE (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 3/10/2025 | 61NCA83ESCITALOPRAM OXALATE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/10/2025 | 61NCA83ESCITALOPRAM OXALATE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 61ECY04BUDESONIDE (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/16/2025 | 66PDO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/16/2025 | 61WCY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/10/2025 | 61JCY16ROSUVASTATIN CALCIUM | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 61EBY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/27/2024 | 61JCA16ROSUVASTATIN CALCIUM | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 61JCA16ROSUVASTATIN CALCIUM | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/17/2024 | 64TCA09IMATINIB MESYLATE (IMMUNOSUPPRESSIVE) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/7/2024 | 61JCA16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 10/1/2024 | 62TDB06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | Division of Southeast Imports (DSEI) | |
| 9/27/2024 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2024 | 60SCS99ANTACID, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/25/2024 | 61JDC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 7/23/2024 | 61JDB99ANTI-CHOLESTEREMIC, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 63FCA06DIGOXIN (CARDIOTONIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 7/16/2024 | 64GDC19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2024 | 61FCA63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/24/2024 | 65RDY01CALCIUM CHLORIDE (REPLENISHER) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/16/2024 | 61PDC31GLIMEPIRIDE (ANTI-DIABETIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/14/2024 | 61NCE76PAROXETINE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/6/2024 | 66NCA03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 62TCS06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 62OCY43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/17/2024 | 61JIY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/26/2024 | 62ICA85LETROZOLE (ANTI-NEOPLASTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 3/21/2024 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/15/2024 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/15/2024 | 62GIC49NAPROXEN (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2024 | 61EBY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/22/2024 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/22/2023 | 62IDY85LETROZOLE (ANTI-NEOPLASTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/22/2023 | 61WCJ99A-FUNGAL N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/6/2023 | 62FDO36SILVER NITRATE (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/28/2023 | 62ICA31METHOTREXATE (ANTI-NEOPLASTIC) | Division of Southeast Imports (DSEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 63OCP07SUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/10/2023 | 61XCP50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 3/28/2023 | 62OCE24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 63OCP07SUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 63OCP07SUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/23/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62JDA09LEVODOPA (ANTI-PARKINSONIAN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62JDA09LEVODOPA (ANTI-PARKINSONIAN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62ICA72CAPECITABINE (ANTI-NEOPLASTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62ICA72CAPECITABINE (ANTI-NEOPLASTIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62GCK94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62GCK94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 60LCA69TRAMADOL HCL (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 60LCA69TRAMADOL HCL (ANALGESIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 62OCE24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/10/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/2/2023 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/2/2023 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 65PCE03TAMSULOSIN HCL (REGULATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61NCA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 62GCK94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 62GCK94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61NCA69GABAPENTIN (ANTI-DEPRESSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61MCF24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61MCF24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 2/1/2023 | 61MCF24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries Ltd.'s FDA import refusal history?
Sun Pharmaceutical Industries Ltd. (FEI: 3002809586) has 117 FDA import refusal record(s) in our database, spanning from 9/3/2009 to 11/25/2025.
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.'s FEI number is 3002809586.
What types of violations has Sun Pharmaceutical Industries Ltd. received?
Sun Pharmaceutical Industries Ltd. 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. come from?
All FDA import refusal data for Sun Pharmaceutical Industries Ltd. 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.