ZYDUS HEALTHCARE LIMITED
⚠️ Moderate Risk
FEI: 3030419808 • Namchi, Sikkim • INDIA
FEI Number
3030419808
Location
Namchi, Sikkim
Country
INDIAAddress
Sikkim, Bhagey Hola Nh Majhitarrangpo, Namchi, Sikkim, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/16/2024 | 63BDB30THEOPHYLLINE (BRONCHODILATOR) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZYDUS HEALTHCARE LIMITED's FDA import refusal history?
ZYDUS HEALTHCARE LIMITED (FEI: 3030419808) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2024 to 2/16/2024.
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 LIMITED's FEI number is 3030419808.
What types of violations has ZYDUS HEALTHCARE LIMITED received?
ZYDUS HEALTHCARE LIMITED 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 LIMITED come from?
All FDA import refusal data for ZYDUS HEALTHCARE 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.