Zydus Healthcare
⚠️ High Risk
FEI: 3007517883 • Rangpo Sikkim • INDIA
FEI Number
3007517883
Location
Rangpo Sikkim
Country
INDIAAddress
N.H. No 31 A Majhitar, , Rangpo Sikkim, , 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 |
|---|---|---|---|
| 11/13/2025 | 63BCY26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2025 | 63BCY26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2025 | 61NDY76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 63BCY30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2015 | 63BDY30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/16/2015 | 61PDY31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/9/2012 | 64GCA13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/21/2012 | 60SDA20CALCIUM ACETATE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 64GCA13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/12/2009 | 60LCE69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Zydus Healthcare's FDA import refusal history?
Zydus Healthcare (FEI: 3007517883) has 11 FDA import refusal record(s) in our database, spanning from 11/12/2009 to 11/13/2025.
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. Zydus Healthcare's FEI number is 3007517883.
What types of violations has Zydus Healthcare received?
Zydus Healthcare 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 Zydus Healthcare come from?
All FDA import refusal data for Zydus Healthcare 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.