Aurobindo Pharma Limited
⚠️ High Risk
FEI: 3003493712 • Ameerpet • INDIA
FEI
FEI Number
3003493712
📍
Location
Ameerpet
🇮🇳
Country
INDIA🏢
Address
Plot 2 Maithri Vihar Ameerpet, , Ameerpet, , India
High Risk
FDA Import Risk Assessment
58.3
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
101
Total Refusals
5
Unique Violations
6/15/2020
Latest Refusal
10/3/2001
Earliest Refusal
Score Breakdown
Violation Severity
76.5×40%
Refusal Volume
74.4×30%
Recency
0.0×20%
Frequency
54.0×10%
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
7567×
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).
11833×
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).
1221×
ANTIBIOTIC
The drug appears to purport, or represented as, being composed wholly or partly of an antibiotic and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 507. REPEALED11/97
161×
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
1791×
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 |
|---|---|---|---|
| 6/15/2020 | 62VDA79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 62VDY79LOPINAVIR; RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2020 | 62VDY99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 62LCS54LOPINAVIR (ANTI-PROTOZOAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/6/2017 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/20/2016 | 61WCZ59VORICONAZOLE | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/23/2015 | 61NCC74MODAFINIL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2013 | 61JCY12LOVASTATIN (ANTI-CHOLESTEREMIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/21/2010 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/21/2010 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/2/2010 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/2/2010 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/5/2010 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2010 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2010 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2010 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2010 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2010 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2008 | 56BCZ07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/12/2008 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/12/2008 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/12/2008 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/18/2008 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/18/2008 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/18/2008 | 61FDY30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/18/2008 | 61FDY30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2007 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2007 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2007 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/7/2007 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/1/2007 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 8/1/2007 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 4/26/2007 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/26/2007 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/26/2007 | 56BCZ03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/23/2007 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/23/2007 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/23/2007 | 61NDA65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/5/2006 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/5/2006 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/5/2006 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/5/2006 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/27/2005 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/27/2005 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/27/2005 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/27/2005 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/8/2005 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2005 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2005 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2005 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2005 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2005 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2005 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/28/2005 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/28/2005 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/28/2005 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/28/2005 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/28/2005 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/31/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/17/2004 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 61GCS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2004 | 61FCS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/19/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/20/2003 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/20/2003 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 56YYY99ANTIBIOTIC N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 61GCS57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 61FCS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 61FCS14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/12/2003 | 61FCS55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/12/2003 | 56CCS27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/12/2003 | 56ACS10PENICILLIN G, NATURAL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/25/2003 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/15/2003 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/9/2002 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/9/2002 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/9/2002 | 56YYY99ANTIBIOTIC N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/9/2002 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2002 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 122ANTIBIOTIC | Florida District Office (FLA-DO) |
| 8/2/2002 | 56YYY99ANTIBIOTIC N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2002 | 56YYY99ANTIBIOTIC N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2002 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2002 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/26/2002 | 56BYY19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/26/2002 | 56BYY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/26/2002 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/24/2002 | 56ACS10PENICILLIN G, NATURAL | 179AGR RX | Florida District Office (FLA-DO) |
| 12/20/2001 | 56YYY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/3/2001 | 66VBS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/3/2001 | 56ACS10PENICILLIN G, NATURAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/3/2001 | 66VBS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Aurobindo Pharma Limited's FDA import refusal history?
Aurobindo Pharma Limited (FEI: 3003493712) has 101 FDA import refusal record(s) in our database, spanning from 10/3/2001 to 6/15/2020.
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. Aurobindo Pharma Limited's FEI number is 3003493712.
What types of violations has Aurobindo Pharma Limited received?
Aurobindo Pharma Limited has been cited for 5 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.