Aristo Pharmaceuticals Ltd
⚠️ High Risk
FEI: 3004508440 • Mandideep Dist-Raisen, Madya Pradesh • INDIA
FEI Number
3004508440
Location
Mandideep Dist-Raisen, Madya Pradesh
Country
INDIAAddress
Plots 208, 76-77, New Industrial Area #2, Mandideep Dist-Raisen, Madya Pradesh, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2024 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2012 | 65QCA24ORPHENADRINE CITRATE (RELAXANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/12/2009 | 62GDA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aristo Pharmaceuticals Ltd's FDA import refusal history?
Aristo Pharmaceuticals Ltd (FEI: 3004508440) has 3 FDA import refusal record(s) in our database, spanning from 11/12/2009 to 8/2/2024.
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 Pharmaceuticals Ltd's FEI number is 3004508440.
What types of violations has Aristo Pharmaceuticals Ltd received?
Aristo Pharmaceuticals 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 Pharmaceuticals Ltd come from?
All FDA import refusal data for Aristo Pharmaceuticals 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.