Cipla, Ltd.
⚠️ High Risk
FEI: 3002806702 • Dist. Pune, Maharashtra • INDIA
FEI Number
3002806702
Location
Dist. Pune, Maharashtra
Country
INDIAAddress
Plots D-7, D-22, D-27, M.I.D.C. Industrial Area, Taluka-Daund, Kurkumbh Village, Dist. Pune, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2025 | 60LDB99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2025 | 60CDB99ADRENERGIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2023 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/24/2023 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/12/2018 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2010 | 64XCA11ISOTRETINOIN (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/1/2010 | 64UCS06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 5/14/2007 | 61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/6/2007 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/3/2005 | 61WCS45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/11/2005 | 61ADA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Cipla, Ltd.'s FDA import refusal history?
Cipla, Ltd. (FEI: 3002806702) has 11 FDA import refusal record(s) in our database, spanning from 2/11/2005 to 4/14/2025.
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, Ltd.'s FEI number is 3002806702.
What types of violations has Cipla, Ltd. received?
Cipla, Ltd. 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, Ltd. come from?
All FDA import refusal data for Cipla, 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.