ARISTO PHARMACEUTCALS PVT LTD
⚠️ High Risk
FEI: 3013947420 • East Ikkim • INDIA
FEI Number
3013947420
Location
East Ikkim
Country
INDIAAddress
Plot No 2040-46, , East Ikkim, , 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 ARISTO PHARMACEUTCALS PVT LTD's FDA import refusal history?
ARISTO PHARMACEUTCALS PVT LTD (FEI: 3013947420) has 3 FDA import refusal record(s) in our database, spanning from 7/16/2021 to 11/17/2025.
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. ARISTO PHARMACEUTCALS PVT LTD's FEI number is 3013947420.
What types of violations has ARISTO PHARMACEUTCALS PVT LTD received?
ARISTO PHARMACEUTCALS PVT 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 ARISTO PHARMACEUTCALS PVT LTD come from?
All FDA import refusal data for ARISTO PHARMACEUTCALS PVT 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.