ARISTO PHARMA
⚠️ High Risk
FEI: 3014937513 • Mandideep • INDIA
FEI Number
3014937513
Location
Mandideep
Country
INDIAAddress
Plot No 208, New Indust, , Mandideep, , 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 61LCY29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 65JCY10DYDROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 60LCY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2024 | 62KIE99ANTI-PERISTALTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/29/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ARISTO PHARMA's FDA import refusal history?
ARISTO PHARMA (FEI: 3014937513) has 6 FDA import refusal record(s) in our database, spanning from 4/29/2020 to 9/24/2025.
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 PHARMA's FEI number is 3014937513.
What types of violations has ARISTO PHARMA received?
ARISTO PHARMA has been cited for 2 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 PHARMA come from?
All FDA import refusal data for ARISTO PHARMA 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.