Cadila Pharmaceuticals Limited
⚠️ Moderate Risk
FEI: 3002806711 • Ankleshwar • INDIA
FEI Number
3002806711
Location
Ankleshwar
Country
INDIAAddress
294, G.I.D.C. Industrial Estate, , Ankleshwar, , India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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.
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 |
|---|---|---|---|
| 1/20/2015 | 61NCE66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2011 | 60SDA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/23/2011 | 62FCS08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/17/2004 | 61HDS22ETHAMBUTOL HYDROCHLORIDE (ANTI-BACTERIAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Cadila Pharmaceuticals Limited's FDA import refusal history?
Cadila Pharmaceuticals Limited (FEI: 3002806711) has 4 FDA import refusal record(s) in our database, spanning from 8/17/2004 to 1/20/2015.
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 3002806711.
What types of violations has Cadila Pharmaceuticals Limited received?
Cadila Pharmaceuticals Limited has been cited for 2 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.