Aristo Pharmaceuticals Pvt., Ltd.
⚠️ Moderate Risk
FEI: 3003416980 • Village Dhabel, Daman and Diu • INDIA
FEI Number
3003416980
Location
Village Dhabel, Daman and Diu
Country
INDIAAddress
Survey 371, Kumbar Falia,, Village Dhabel, Daman and Diu, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 9/8/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 62TDA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/17/2009 | 66MDA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/11/2008 | 61PCP61ROSIGLITAZONE MALEATE/METFORMIN HCI | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aristo Pharmaceuticals Pvt., Ltd.'s FDA import refusal history?
Aristo Pharmaceuticals Pvt., Ltd. (FEI: 3003416980) has 5 FDA import refusal record(s) in our database, spanning from 3/11/2008 to 9/8/2020.
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 Pvt., Ltd.'s FEI number is 3003416980.
What types of violations has Aristo Pharmaceuticals Pvt., Ltd. received?
Aristo Pharmaceuticals 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 Pharmaceuticals Pvt., Ltd. come from?
All FDA import refusal data for Aristo Pharmaceuticals 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.