Aurobindo Pharma Limited
⚠️ High Risk
FEI: 3004021263 • Sangareddy, Telangana • INDIA
FEI Number
3004021263
Location
Sangareddy, Telangana
Country
INDIAAddress
Unit-VI, Chitkul Village, Patancheru Mandal, Sy. No.329/39 & 329/47, Sangareddy, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2011 | 56CCR65CEFPROZIL (CEPHALOSPORINS) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 11/3/2011 | 56CCR65CEFPROZIL (CEPHALOSPORINS) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 6/2/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 6/2/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 6/2/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/21/2011 | 56CCR25SODIUM CEPHALOTHIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/21/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/21/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/21/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/21/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/21/2011 | 56CCP52CEFDINIR (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/18/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/18/2011 | 56CCP52CEFDINIR (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/18/2011 | 56CCR65CEFPROZIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 4/13/2011 | 56CDK72CEFUROXIME SODIUM (CEPHALOSPORINS) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCP52CEFDINIR (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCR64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCA65CEFPROZIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCA65CEFPROZIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCR64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCR64CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 3/30/2011 | 56CCE27CEPHALEXIN (CEPHALOSPORINS) | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Aurobindo Pharma Limited's FDA import refusal history?
Aurobindo Pharma Limited (FEI: 3004021263) has 32 FDA import refusal record(s) in our database, spanning from 3/30/2011 to 11/3/2011.
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 3004021263.
What types of violations has Aurobindo Pharma Limited received?
Aurobindo Pharma Limited 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 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.