ZANDU PHARMACEUTICAL WORKS LTD
⚠️ High Risk
FEI: 3017227181 • Kolkata, West Bengal • INDIA
FEI Number
3017227181
Location
Kolkata, West Bengal
Country
INDIAAddress
687 Emami, E M Bypass Road, Kolkata, West Bengal, 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 ZANDU PHARMACEUTICAL WORKS LTD's FDA import refusal history?
ZANDU PHARMACEUTICAL WORKS LTD (FEI: 3017227181) has 2 FDA import refusal record(s) in our database, spanning from 2/15/2022 to 12/1/2025.
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. ZANDU PHARMACEUTICAL WORKS LTD's FEI number is 3017227181.
What types of violations has ZANDU PHARMACEUTICAL WORKS LTD received?
ZANDU PHARMACEUTICAL WORKS LTD 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 ZANDU PHARMACEUTICAL WORKS LTD come from?
All FDA import refusal data for ZANDU PHARMACEUTICAL WORKS LTD 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.