Vasudha Pharma Chem Limited
⚠️ Moderate Risk
FEI: 3002093078 • Hyderabad, Telangana • INDIA
FEI Number
3002093078
Location
Hyderabad, Telangana
Country
INDIAAddress
Unit-I, Plot No. 37/A, 38, 39 A & B, Phase-1, IDA, Jeedimetla, Hyderabad, Telangana, 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
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.
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2019 | 61TCT31DOMPERIDONE | Division of Southwest Imports (DSWI) | |
| 5/4/2018 | 60SQT21CISAPRIDE (ANTACID) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 6/14/2016 | 61TAB31DOMPERIDONE | Division of Southeast Imports (DSEI) | |
| 9/3/2015 | 61ECA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/3/2015 | 61TAB31DOMPERIDONE | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/2/2015 | 65QCR60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | Seattle District Office (SEA-DO) | |
| 9/2/2015 | 65QCT60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | Seattle District Office (SEA-DO) | |
| 2/5/2014 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/10/2014 | 61XCS14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 9/4/2013 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2011 | 61TCS31DOMPERIDONE | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 61TCY99ANTI-EMETIC/NAUSEANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/27/2011 | 61TCY99ANTI-EMETIC/NAUSEANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 4/25/2011 | 61TCY99ANTI-EMETIC/NAUSEANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 4/22/2011 | 61TDY31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/11/2011 | 61TIY31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/13/2010 | 61TCY31DOMPERIDONE | Cincinnati District Office (CIN-DO) | |
| 8/23/2010 | 61TCY31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 7/23/2010 | 61TIY99ANTI-EMETIC/NAUSEANT N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/13/2010 | 61TCS31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/13/2010 | 61TCS31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/13/2010 | 61TAS31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 3/8/2010 | 61TCS31DOMPERIDONE | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/8/2009 | 61TIY12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/8/2009 | 61TIY12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/8/2009 | 61TIY12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 11/21/2008 | 66MCB36HALOPERIDOL (TRANQUILIZER) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2008 | 60SDR21CISAPRIDE (ANTACID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/15/2002 | 62UAZ11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | New York District Office (NYK-DO) | |
| 8/16/2002 | 61TAS99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Vasudha Pharma Chem Limited's FDA import refusal history?
Vasudha Pharma Chem Limited (FEI: 3002093078) has 30 FDA import refusal record(s) in our database, spanning from 8/16/2002 to 4/9/2019.
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. Vasudha Pharma Chem Limited's FEI number is 3002093078.
What types of violations has Vasudha Pharma Chem Limited received?
Vasudha Pharma Chem Limited has been cited for 6 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 Vasudha Pharma Chem Limited come from?
All FDA import refusal data for Vasudha Pharma Chem 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.