Cipla Limited
⚠️ High Risk
FEI: 3007021905 • Mumbai, Maharashtra • INDIA
FEI Number
3007021905
Location
Mumbai, Maharashtra
Country
INDIAAddress
Lal Bahadur Shastri Marg, , 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2025 | 65PDY03TAMSULOSIN HCL (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 61GCA85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2023 | 61GCA84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2023 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/28/2016 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/13/2016 | 62OCC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/11/2016 | 61XDE50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/9/2016 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/13/2016 | 61EDY99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/13/2016 | 61WDB04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/6/2016 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/2/2015 | 56CCY54CEFIXIME (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 56GYY50NYSTATIN (ANTIFUNGAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/23/2015 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/29/2015 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/20/2015 | 60XAB17ATENOLOL (ANTI-ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 1/20/2015 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | Division of Southeast Imports (DSEI) | |
| 1/20/2015 | 61PCB07GLIBORNURIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 12/17/2014 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/25/2014 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/24/2014 | 61JCY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/21/2014 | 62GIS99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 11/29/2013 | 56ODJ99(FLUOROQUINOLONE) N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/29/2013 | 56JDJ31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/21/2012 | 62VDA42VALACYCLOVIR HCL (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 60CDA49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 62LDA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/7/2011 | 60VAS01DANAZOL (ANTERIOR PITUITARY SUPPRESSOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 64UAA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/14/2011 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/6/2010 | 61JIK08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/6/2010 | 62VIA15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/25/2010 | 62GDB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/22/2010 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/2/2010 | 63BAQ01ALBUTEROL (BRONCHODILATOR) | New York District Office (NYK-DO) | |
| 9/22/2008 | 61WCS45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/3/2008 | 65VCP15DIAZEPAM (SEDATIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/3/2008 | 62OCP29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/23/2008 | 62GDJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2007 | 61XCA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/15/2007 | 62OCA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/26/2007 | 62ODB44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2007 | 62GDC99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/7/2006 | 77ETLNASAL FLOWMETER, | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/18/2006 | 61EBY04BUDESONIDE (ANTI-ASTHMATIC) | Seattle District Office (SEA-DO) | |
| 11/25/2005 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2005 | 61PDB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/8/2005 | 60ICS99ALKALIZER, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2005 | 65PCA03TAMSULOSIN HCL (REGULATOR) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/1/2005 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 62VDC32LAMIVUDINE (ANTI-VIRAL) | New Orleans District Office (NOL-DO) | |
| 7/20/2005 | 62KSY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 473LABELING | New York District Office (NYK-DO) |
| 6/14/2005 | 65PAP02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2005 | 61ECY11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/7/2005 | 60MDB99ANALGESIC, NARCOTIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/5/2005 | 60WDL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/5/2005 | 60WDB01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/14/2005 | 61PDB11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 61JCB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/14/2005 | 65PAP02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2004 | 60SCS25RANITIDINE HYDROCHLORIDE (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/18/2004 | 61FCS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/14/2004 | 64SDA10FLURAZEPAM HCL (HYPNOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/6/2004 | 61ELR99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/19/2004 | 61GCS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 61FCS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 56ICS35ERYTHROMYCIN STEARATE (MACROLIDES) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 61FCS30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/22/2003 | 60LCB99ANALGESIC, N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 11/26/2003 | 61NDF80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/15/2003 | 65PCS02SILDENAFIL CITRATE (REGULATOR) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/18/2003 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/11/2002 | 62IDK91PACLITAXEL (ANTI-NEOPLASTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Cipla Limited's FDA import refusal history?
Cipla Limited (FEI: 3007021905) has 83 FDA import refusal record(s) in our database, spanning from 12/11/2002 to 6/6/2025.
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. Cipla Limited's FEI number is 3007021905.
What types of violations has Cipla Limited received?
Cipla Limited has been cited for 7 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 Cipla Limited come from?
All FDA import refusal data for Cipla 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.