ZYDUS HEALTH CARE LIMITED
⚠️ High Risk
FEI: 3027726495 • East Mumbai • INDIA
FEI Number
3027726495
Location
East Mumbai
Country
INDIAAddress
No 460/6 I B Patel Roadvillage Pahadi Gorgegaon, , East Mumbai, , 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 HEALTH CARE LIMITED's FDA import refusal history?
ZYDUS HEALTH CARE LIMITED (FEI: 3027726495) has 2 FDA import refusal record(s) in our database, spanning from 1/8/2025 to 2/12/2025.
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 HEALTH CARE LIMITED's FEI number is 3027726495.
What types of violations has ZYDUS HEALTH CARE LIMITED received?
ZYDUS HEALTH CARE 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 HEALTH CARE LIMITED come from?
All FDA import refusal data for ZYDUS HEALTH CARE 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.