Aurobindo Pharma Limited
⚠️ High Risk
FEI: 3007373532 • Mahabubnagar, Telangana • INDIA
FEI Number
3007373532
Location
Mahabubnagar, Telangana
Country
INDIAAddress
Unit-VII, Sy No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot S1 Part SEZ, TSIIC, Green Industrial Park, Polepally, , Jedcherla Mandal, Mahabubnagar, Telangana, 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
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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 |
|---|---|---|---|
| 11/9/2022 | 63OCT07SUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
| 1/18/2013 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 186INSANITARY | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Aurobindo Pharma Limited's FDA import refusal history?
Aurobindo Pharma Limited (FEI: 3007373532) has 8 FDA import refusal record(s) in our database, spanning from 1/18/2013 to 11/9/2022.
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 Limited's FEI number is 3007373532.
What types of violations has Aurobindo Pharma Limited received?
Aurobindo Pharma Limited 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 Limited come from?
All FDA import refusal data for Aurobindo Pharma Limited 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.