Cipla India Ltd
⚠️ High Risk
FEI: 3005383382 • Dist. Solan • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2019 | 62OCA43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2017 | 66MCY86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/4/2017 | 66MCY86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/28/2016 | 63BDY01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/3/2016 | 62OCE44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2015 | 61EDY99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/14/2014 | 62JCY08ETHOPROPAZINE HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/25/2011 | 61LCB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/25/2011 | 62OCB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Cipla India Ltd's FDA import refusal history?
Cipla India Ltd (FEI: 3005383382) has 10 FDA import refusal record(s) in our database, spanning from 2/25/2011 to 3/28/2023.
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 India Ltd's FEI number is 3005383382.
What types of violations has Cipla India Ltd received?
Cipla India Ltd has been cited for 1 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 India Ltd come from?
All FDA import refusal data for Cipla India 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.