Vignesh Life Science Pvt Ltd
⚠️ Moderate Risk
FEI: 3009436805 • Hyderabad, Tamil Nadu • INDIA
FEI Number
3009436805
Location
Hyderabad, Tamil Nadu
Country
INDIAAddress
202 Sarada Residency, H - 26 , Madhura Nagar Ameerpet, Hyderabad, Tamil Nadu, 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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2011 | 61FCY53CEFADROXIL MONOHYDRATE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Cincinnati District Office (CIN-DO) | |
| 5/31/2011 | 64BBZ99DIURETIC N.E.C. | Chicago District Office (CHI-DO) | |
| 3/1/2010 | 63VCR03MONOBENZONE (DEPIGMENTOR) | Seattle District Office (SEA-DO) | |
| 5/3/2007 | 60LCY66SODIUM SALICYLATE (ANALGESIC) | New York District Office (NYK-DO) | |
| 5/3/2007 | 61TCY11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vignesh Life Science Pvt Ltd's FDA import refusal history?
Vignesh Life Science Pvt Ltd (FEI: 3009436805) has 5 FDA import refusal record(s) in our database, spanning from 5/3/2007 to 11/21/2011.
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. Vignesh Life Science Pvt Ltd's FEI number is 3009436805.
What types of violations has Vignesh Life Science Pvt Ltd received?
Vignesh Life Science 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 Vignesh Life Science Pvt Ltd come from?
All FDA import refusal data for Vignesh Life Science 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.