ZYDUS MEDICA ZYDUS HEALTH CARE
⚠️ High Risk
FEI: 3020976327 • Ahmedabad • INDIA
FEI Number
3020976327
Location
Ahmedabad
Country
INDIAAddress
Plot No 407 Ahmedabad I, , Ahmedabad, , 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
Frequently Asked Questions
What is ZYDUS MEDICA ZYDUS HEALTH CARE's FDA import refusal history?
ZYDUS MEDICA ZYDUS HEALTH CARE (FEI: 3020976327) has 2 FDA import refusal record(s) in our database, spanning from 6/17/2024 to 11/10/2025.
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 MEDICA ZYDUS HEALTH CARE's FEI number is 3020976327.
What types of violations has ZYDUS MEDICA ZYDUS HEALTH CARE received?
ZYDUS MEDICA ZYDUS HEALTH CARE 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 MEDICA ZYDUS HEALTH CARE come from?
All FDA import refusal data for ZYDUS MEDICA ZYDUS HEALTH CARE 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.