ZYDUS MEDICA
⚠️ Moderate Risk
FEI: 3016928932 • East Sikkim • INDIA
FEI Number
3016928932
Location
East Sikkim
Country
INDIAAddress
967p 968p 970p Durga Ci, , East 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
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's FDA import refusal history?
ZYDUS MEDICA (FEI: 3016928932) has 2 FDA import refusal record(s) in our database, spanning from 3/12/2021 to 3/12/2021.
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's FEI number is 3016928932.
What types of violations has ZYDUS MEDICA received?
ZYDUS MEDICA 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 come from?
All FDA import refusal data for ZYDUS MEDICA 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.