Ciron Drugs & Pharmaceuticals Pvt Ltd
⚠️ Moderate Risk
FEI: 3006730169 • Mumbai, Maharashtra • INDIA
FEI Number
3006730169
Location
Mumbai, Maharashtra
Country
INDIAAddress
1, Prabhat Nagar, Patel Estate Road, Mumbai, Maharashtra, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2016 | 62CCC10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2015 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/4/2015 | 66MCB36HALOPERIDOL (TRANQUILIZER) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 61MCL23PHENYTOIN (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/28/2015 | 61MCL23PHENYTOIN (ANTI-CONVULSANT) | Florida District Office (FLA-DO) | |
| 7/28/2015 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | Florida District Office (FLA-DO) | |
| 7/28/2015 | 60LCA69TRAMADOL HCL (ANALGESIC) | Florida District Office (FLA-DO) | |
| 7/28/2015 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | Florida District Office (FLA-DO) | |
| 1/16/2015 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/5/2014 | 64LIK60TRIAMCINOLONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 3/28/2013 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 1/17/2013 | 62GCB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2013 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2013 | 66MCB36HALOPERIDOL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2013 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2012 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2012 | 61MCL23PHENYTOIN (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2012 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 62GCB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/21/2012 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2011 | 62CBB10CLONIDINE HCL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 6/2/2010 | 63BAQ01ALBUTEROL (BRONCHODILATOR) | New York District Office (NYK-DO) | |
| 11/20/2008 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ciron Drugs & Pharmaceuticals Pvt Ltd's FDA import refusal history?
Ciron Drugs & Pharmaceuticals Pvt Ltd (FEI: 3006730169) has 25 FDA import refusal record(s) in our database, spanning from 11/20/2008 to 10/14/2016.
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. Ciron Drugs & Pharmaceuticals Pvt Ltd's FEI number is 3006730169.
What types of violations has Ciron Drugs & Pharmaceuticals Pvt Ltd received?
Ciron Drugs & Pharmaceuticals Pvt Ltd 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 Ciron Drugs & Pharmaceuticals Pvt Ltd come from?
All FDA import refusal data for Ciron Drugs & Pharmaceuticals Pvt 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.