Cadila Pharmaceuticals Limited
⚠️ High Risk
FEI: 3007684569 • Ahmedabad, Gujarat • INDIA
FEI Number
3007684569
Location
Ahmedabad, Gujarat
Country
INDIAAddress
1389 Trasad Road, Dholka, Ahmedabad, Gujarat, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2025 | 54AFY99VITAMIN, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/20/2025 | 60ZCA02ALBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2025 | 61EAA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2024 | 64LCP60TRIAMCINOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2021 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2018 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 60ZCA99ANTIPARASITIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2016 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2012 | 56CCH99CEPHALOSPORIN N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/18/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 1/12/2005 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New York District Office (NYK-DO) |
| 1/5/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/5/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Cadila Pharmaceuticals Limited's FDA import refusal history?
Cadila Pharmaceuticals Limited (FEI: 3007684569) has 13 FDA import refusal record(s) in our database, spanning from 1/5/2005 to 12/17/2025.
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. Cadila Pharmaceuticals Limited's FEI number is 3007684569.
What types of violations has Cadila Pharmaceuticals Limited received?
Cadila Pharmaceuticals 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 Cadila Pharmaceuticals Limited come from?
All FDA import refusal data for Cadila Pharmaceuticals 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.