Sun Pharmaceutical Industries (prev. Ranbaxy)
⚠️ High Risk
FEI: 3002807977 • Dewas, Madhya Pradesh • INDIA
FEI Number
3002807977
Location
Dewas, Madhya Pradesh
Country
INDIAAddress
3 Industrial Area, , Dewas, Madhya Pradesh, 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
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).
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).
TAMPERING
It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2025 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 56CDA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/11/2024 | 61WDO47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/19/2024 | 56CDA64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 61HCE99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2022 | 56CCY64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2022 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/14/2022 | 61WDA99A-FUNGAL N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/6/2022 | 56YDY99ANTIBIOTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/19/2021 | 56CCY73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2021 | 56CCY99CEPHALOSPORIN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2021 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 56CCA64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2012 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/14/2011 | 56CDZ27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2010 | 56YAF99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/26/2010 | 56ICA76AZITHROMYCIN (MACAROLIDES) | Cincinnati District Office (CIN-DO) | |
| 1/26/2010 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) | |
| 1/26/2010 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) | |
| 10/10/2008 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 339TAMPERING | Division of Southeast Imports (DSEI) |
| 10/10/2008 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 339TAMPERING | Division of Southeast Imports (DSEI) |
| 10/10/2008 | 56BCR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 339TAMPERING | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BDR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 61JAC09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BDR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BCR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56CCK71CEFUROXIME AXETIL (CEPHALOSPORINS) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 62ODA34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 10/10/2008 | 56BCR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 3/12/2007 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2007 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/20/2001 | 61FCE54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sun Pharmaceutical Industries (prev. Ranbaxy)'s FDA import refusal history?
Sun Pharmaceutical Industries (prev. Ranbaxy) (FEI: 3002807977) has 35 FDA import refusal record(s) in our database, spanning from 11/20/2001 to 2/27/2025.
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 (prev. Ranbaxy)'s FEI number is 3002807977.
What types of violations has Sun Pharmaceutical Industries (prev. Ranbaxy) received?
Sun Pharmaceutical Industries (prev. Ranbaxy) 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 (prev. Ranbaxy) come from?
All FDA import refusal data for Sun Pharmaceutical Industries (prev. Ranbaxy) 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.