VEDIKROOTS
⚠️ High Risk
FEI: 3027643347 • Nodia • INDIA
FEI Number
3027643347
Location
Nodia
Country
INDIAAddress
F-7 Backside Lower Basement, Sector - Nodia, Nodia, , 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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2024 | 66YBY07DRUG ENVIRONMENTAL SWABS/SAMPLES, OTHER DRUG RELATED ITEMS | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 260FALSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VEDIKROOTS's FDA import refusal history?
VEDIKROOTS (FEI: 3027643347) has 4 FDA import refusal record(s) in our database, spanning from 5/22/2024 to 5/22/2024.
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. VEDIKROOTS's FEI number is 3027643347.
What types of violations has VEDIKROOTS received?
VEDIKROOTS has been cited for 2 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 VEDIKROOTS come from?
All FDA import refusal data for VEDIKROOTS 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.