Cipla Limited
⚠️ High Risk
FEI: 3004081307 • Salcette, Goa • INDIA
FEI Number
3004081307
Location
Salcette, Goa
Country
INDIAAddress
L139 to L146, S-103 to S-105, S-107 to S-112, L147 to L-147/1/2/3, L-147A, L-138, L-150, S-116, Verna Industrial Area, Salcette, Goa, 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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2025 | 66OCA01ELTROMBOPAG OLAMINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/8/2021 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 66SDY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 56KCY85VANCOMYCIN HYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2020 | 64UDY06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2020 | 61PCY99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2020 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/2/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2020 | 62ODY09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 61GDA84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2020 | 62VDY75EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 66FCL99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 66FCL99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2017 | 66SDY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2017 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2016 | 61NDE65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/15/2016 | 66SDB03BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/14/2015 | 61EDY11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/14/2015 | 61EDY04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/14/2015 | 63BDY01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/9/2014 | 61EIY04BUDESONIDE (ANTI-ASTHMATIC) | New Orleans District Office (NOL-DO) | |
| 8/15/2012 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/27/2012 | 64GCA20FENESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2012 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 66BAY99STIMULANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 63BAF26IPRATROPIUM BROMIDE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 61EAY04BUDESONIDE (ANTI-ASTHMATIC) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 64LAF02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 66BAY26NIKETHAMIDE (STIMULANT) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 64LAF02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 63BAF25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 66BAY99STIMULANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 61EAY11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 61EAY11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 63BAY26IPRATROPIUM BROMIDE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 63BAY99BRONCHODILATOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/28/2011 | 63BAF32FORMOTEROL FUMARATE | New Orleans District Office (NOL-DO) | |
| 10/10/2007 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/4/2005 | 63ABC02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/11/2005 | 63BDQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/19/2004 | 63BDY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/19/2004 | 63BDY01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Cipla Limited's FDA import refusal history?
Cipla Limited (FEI: 3004081307) has 47 FDA import refusal record(s) in our database, spanning from 10/19/2004 to 4/3/2025.
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 3004081307.
What types of violations has Cipla Limited received?
Cipla 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 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.