Aurobindo Pharma USA Inc
⚠️ High Risk
FEI: 3008460374 • East Windsor, NJ • UNITED STATES
FEI Number
3008460374
Location
East Windsor, NJ
Country
UNITED STATESAddress
279 Princeton Hightstown Rd, , East Windsor, NJ, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2025 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 66FDY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 61NDA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 63ADA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2020 | 61JCL16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2020 | 62VDY12RIBAVIRIN (ANTI-VIRAL) | 179AGR RX | Division of Southeast Imports (DSEI) |
| 1/26/2016 | 61NDY80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Aurobindo Pharma USA Inc's FDA import refusal history?
Aurobindo Pharma USA Inc (FEI: 3008460374) has 7 FDA import refusal record(s) in our database, spanning from 1/26/2016 to 8/11/2025.
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. Aurobindo Pharma USA Inc's FEI number is 3008460374.
What types of violations has Aurobindo Pharma USA Inc received?
Aurobindo Pharma USA Inc 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 Aurobindo Pharma USA Inc come from?
All FDA import refusal data for Aurobindo Pharma USA Inc 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.