Aurobindo Pharma Ltd
⚠️ Moderate Risk
FEI: 3004021229 • Medchal, Telangana • INDIA
FEI Number
3004021229
Location
Medchal, Telangana
Country
INDIAAddress
Unit 3, Survey 313 & 314, Bachupally, Medchal-Malkajgiri District, Medchal, Telangana, 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
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).
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 |
|---|---|---|---|
| 6/29/2021 | 62VDY77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/29/2008 | 56CCA65CEFPROZIL (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 8/29/2008 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 8/29/2008 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 8/29/2008 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 8/29/2008 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 8/20/2008 | 56CCA65CEFPROZIL (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 8/7/2008 | 64BCS25HYDROCHLOROTHIAZIDE (DIURETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/7/2008 | 61KCS22GLYCOPYRROLATE (ANTI-CHOLINERGIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aurobindo Pharma Ltd's FDA import refusal history?
Aurobindo Pharma Ltd (FEI: 3004021229) has 9 FDA import refusal record(s) in our database, spanning from 8/7/2008 to 6/29/2021.
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 Ltd's FEI number is 3004021229.
What types of violations has Aurobindo Pharma Ltd received?
Aurobindo Pharma Ltd 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 Ltd come from?
All FDA import refusal data for Aurobindo Pharma 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.