Genius Nature Herbs Pvt Ltd
⚠️ Moderate Risk
FEI: 3010695866 • Coimbatore South, Tamil Nadu • INDIA
FEI Number
3010695866
Location
Coimbatore South, Tamil Nadu
Country
INDIAAddress
268/1b Siruvani Main Road, , Coimbatore South, 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
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 |
|---|---|---|---|
| 10/16/2014 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Genius Nature Herbs Pvt Ltd's FDA import refusal history?
Genius Nature Herbs Pvt Ltd (FEI: 3010695866) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2014 to 10/16/2014.
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. Genius Nature Herbs Pvt Ltd's FEI number is 3010695866.
What types of violations has Genius Nature Herbs Pvt Ltd received?
Genius Nature Herbs Pvt Ltd 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 Genius Nature Herbs Pvt Ltd come from?
All FDA import refusal data for Genius Nature Herbs 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.