Emami Limited
⚠️ High Risk
FEI: 3014273188 • Vapi, Gujarat • INDIA
FEI Number
3014273188
Location
Vapi, Gujarat
Country
INDIAAddress
Plot No. 82, G.I.D.C., Dist.- Valsad, Vapi (Gujarat), , Vapi, Gujarat, 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 |
|---|---|---|---|
| 1/3/2025 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/29/2024 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/29/2024 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/29/2024 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/29/2024 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/26/2012 | 54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
| 6/26/2012 | 54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Emami Limited's FDA import refusal history?
Emami Limited (FEI: 3014273188) has 7 FDA import refusal record(s) in our database, spanning from 6/26/2012 to 1/3/2025.
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. Emami Limited's FEI number is 3014273188.
What types of violations has Emami Limited received?
Emami Limited 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 Emami Limited come from?
All FDA import refusal data for Emami 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.