Mr Madrnath
⚠️ High Risk
FEI: 3007323497 • Mysore • INDIA
FEI Number
3007323497
Location
Mysore
Country
INDIAAddress
No 862 8th Main A8th Cross, , Mysore, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2009 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/11/2009 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/11/2009 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/11/2009 | 61VDA99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/11/2009 | 62TDE07PANTOPRAZOLE SODIUM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/11/2009 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Mr Madrnath's FDA import refusal history?
Mr Madrnath (FEI: 3007323497) has 6 FDA import refusal record(s) in our database, spanning from 3/11/2009 to 3/11/2009.
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. Mr Madrnath's FEI number is 3007323497.
What types of violations has Mr Madrnath received?
Mr Madrnath has been cited for 1 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 Mr Madrnath come from?
All FDA import refusal data for Mr Madrnath 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.