Bdr Pharmaceutical International
⚠️ High Risk
FEI: 3003981138 • Mumbai, Maharashtra • INDIA
FEI Number
3003981138
Location
Mumbai, Maharashtra
Country
INDIAAddress
407 Sharda Chembers 15, , Mumbai, Maharashtra, 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).
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 |
|---|---|---|---|
| 2/6/2017 | 64UBB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | Florida District Office (FLA-DO) | |
| 8/26/2016 | 64UDB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2016 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2016 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2016 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/20/2016 | 61PAA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2016 | 61NAA69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2016 | 62ZAA16DECITABINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 2/2/2016 | 61TAB31DOMPERIDONE | Division of Southeast Imports (DSEI) | |
| 2/2/2016 | 61ECA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 2/2/2016 | 64UBB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2016 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/2/2016 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2015 | 64UBB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/22/2015 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/6/2015 | 62KCK10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/6/2015 | 56JCK20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/14/2014 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/19/2014 | 64UDL04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | Florida District Office (FLA-DO) | |
| 12/2/2013 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2012 | 64UDZ04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | Division of Southeast Imports (DSEI) | |
| 8/21/2012 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2012 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 7/26/2012 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 6/28/2012 | 61GCR80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 5/13/2010 | 64UCB04CILASTATIN SODIUM/IMIPENEM (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bdr Pharmaceutical International's FDA import refusal history?
Bdr Pharmaceutical International (FEI: 3003981138) has 29 FDA import refusal record(s) in our database, spanning from 5/13/2010 to 2/6/2017.
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. Bdr Pharmaceutical International's FEI number is 3003981138.
What types of violations has Bdr Pharmaceutical International received?
Bdr Pharmaceutical International has been cited for 3 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 Bdr Pharmaceutical International come from?
All FDA import refusal data for Bdr Pharmaceutical International 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.