Lyka Bdr International Ltd
⚠️ High Risk
FEI: 3007522260 • Mumbai • INDIA
FEI Number
3007522260
Location
Mumbai
Country
INDIAAddress
Gate No 3, Unit No. 101, , Mumbai, , 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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 3/6/2017 | 62CCL10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2017 | 61MCL24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2017 | 64PCL04TRANEXAMIC ACID (HEMOSTATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/20/2017 | 62CCL10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/20/2017 | 64LCR41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/20/2017 | 61MCL24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2015 | 60LCA69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2015 | 56BBB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2015 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/10/2015 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/10/2015 | 61JAA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/10/2015 | 60SAB25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/8/2015 | 61FAE53CEFADROXIL MONOHYDRATE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2014 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) | |
| 11/25/2014 | 61LAA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/1/2014 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2014 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2014 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Florida District Office (FLA-DO) | |
| 2/19/2014 | 64UBB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/25/2013 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | Florida District Office (FLA-DO) | |
| 6/25/2013 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | Florida District Office (FLA-DO) | |
| 6/25/2013 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | Florida District Office (FLA-DO) | |
| 5/23/2013 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | Florida District Office (FLA-DO) | |
| 4/15/2013 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 1/9/2013 | 60LCA69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2012 | 56BBB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 60LCL99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/21/2012 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 8/21/2012 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) | |
| 8/6/2012 | 56JAA22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | Division of Southeast Imports (DSEI) | |
| 7/3/2012 | 61FAE53CEFADROXIL MONOHYDRATE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 6/28/2012 | 60LCL99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/30/2012 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2011 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | Florida District Office (FLA-DO) | |
| 10/4/2011 | 62GCB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | Florida District Office (FLA-DO) | |
| 10/4/2011 | 61JAA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | Florida District Office (FLA-DO) | |
| 4/20/2011 | 64UAL04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2011 | 60LCL99ANALGESIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/4/2011 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/9/2011 | 56JCK22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2011 | 56JAA22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/10/2011 | 56JAA22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/10/2011 | 56JAA22CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2010 | 56JAA99LINCOMYCIN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2010 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2010 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/26/2010 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2009 | 60LCL99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/14/2009 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/13/2009 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/28/2009 | 64UDL04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lyka Bdr International Ltd's FDA import refusal history?
Lyka Bdr International Ltd (FEI: 3007522260) has 51 FDA import refusal record(s) in our database, spanning from 4/28/2009 to 3/6/2017.
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. Lyka Bdr International Ltd's FEI number is 3007522260.
What types of violations has Lyka Bdr International Ltd received?
Lyka Bdr International Ltd has been cited for 4 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 Lyka Bdr International Ltd come from?
All FDA import refusal data for Lyka Bdr International 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.