CIPLA LIMITED
🚨 Critical Risk
FEI: 3013137538 • Mumbai, Maharashtra • INDIA
FEI
FEI Number
3013137538
📍
Location
Mumbai, Maharashtra
🇮🇳
Country
INDIA🏢
Address
Cipla House, Peninsula B, Mumbai, Maharashtra, India
Critical Risk
FDA Import Risk Assessment
86.6
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
96
Total Refusals
3
Unique Violations
10/22/2025
Latest Refusal
10/27/2017
Earliest Refusal
Score Breakdown
Violation Severity
88.4×40%
Refusal Volume
73.6×30%
Recency
95.7×20%
Frequency
100.0×10%
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
7595×
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).
1183×
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).
32801×
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2025 | 61HDY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2025 | 63BDY99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2025 | 64LDY37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2025 | 64LDY07BETAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2025 | 61GDA84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2025 | 66VDK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 61WCY46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 61XCA18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 60SDA99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 2/20/2025 | 61ECB04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61XCY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 66TCY01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 60SCY28RANITIDINE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2024 | 60FDY04ZINC STEARATE (ADSORBANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2024 | 60SDY99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2024 | 62TCB07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 9/16/2024 | 62GDY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 60LDY69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 62GDY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 66TCY03FEBUXOSTAT (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61WCA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61WCJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61WCR04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61XDA51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 62LCA37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 60LDY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2024 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 60CAY09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 60ZDY16LEVAMISOLE HYDROCHLORIDE (ANTIPARASITIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/29/2024 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/29/2024 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 62KDA05LOPERAMIDE (ANTI-PERISTALTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 61FDA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2024 | 63BIQ32FORMOTEROL FUMARATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2023 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2023 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2023 | 60XCB02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2023 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2023 | 62GDQ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2022 | 56YCY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 62FCY34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2021 | 63BDY02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2021 | 63BDY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2020 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 61XDA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2020 | 65RCA99REPLENISHER N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2020 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/9/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2020 | 61LCY13WARFARIN SODIUM (ANTI-COAGULANT) | Division of Northern Border Imports (DNBI) | |
| 9/16/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2020 | 64NBA99HEMATINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2020 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/18/2020 | 56IDY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2020 | 62VDY45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2020 | 62LDS54LOPINAVIR (ANTI-PROTOZOAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/13/2020 | 62VDY79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 62VCS45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 62VDY79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 62LCY54LOPINAVIR (ANTI-PROTOZOAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2020 | 62VCS45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2020 | 62VAS57DARUNAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2020 | 62LCS54LOPINAVIR (ANTI-PROTOZOAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/7/2020 | 62VCA45OSELTAMIVIR PHOSPHATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/7/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2020 | 62VDY79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 61BCY04BICALUTAMIDE (ANTI-ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2019 | 61TCK26ONDANSETRON (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2019 | 61ECY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2019 | 62GDK41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2019 | 64UDA08DUTASTERIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 62TDA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2018 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2017 | 63BCP01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2017 | 63BCP01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2017 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 60LDB99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CIPLA LIMITED's FDA import refusal history?
CIPLA LIMITED (FEI: 3013137538) has 96 FDA import refusal record(s) in our database, spanning from 10/27/2017 to 10/22/2025.
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 3013137538.
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.