ZYDUS HEALTHCARE LTS
⚠️ High Risk
FEI: 3014483226 • East Sikkim • INDIA
FEI Number
3014483226
Location
East Sikkim
Country
INDIAAddress
Unite 11 967, 968, 970, , East 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2025 | 63BDY99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2025 | 63BDY99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2025 | 54AFA99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2025 | 61EDY04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 61GDY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 62TDA07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 11/28/2023 | 60SDB27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZYDUS HEALTHCARE LTS's FDA import refusal history?
ZYDUS HEALTHCARE LTS (FEI: 3014483226) has 7 FDA import refusal record(s) in our database, spanning from 11/28/2023 to 10/22/2025.
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 LTS's FEI number is 3014483226.
What types of violations has ZYDUS HEALTHCARE LTS received?
ZYDUS HEALTHCARE LTS 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 ZYDUS HEALTHCARE LTS come from?
All FDA import refusal data for ZYDUS HEALTHCARE LTS 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.