Emami Limited
⚠️ High Risk
FEI: 3006480587 • Kolkata, West Bengal • INDIA
FEI Number
3006480587
Location
Kolkata, West Bengal
Country
INDIAAddress
687 Anandapur E M Bypas, , Kolkata, West Bengal, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2025 | 62MAJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2025 | 60LBJ63SALICYLAMIDE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2024 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/3/2023 | 66PBJ18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/29/2021 | 62FBO99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 11/14/2011 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 8/18/2008 | 60LBL99ANALGESIC, N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Emami Limited's FDA import refusal history?
Emami Limited (FEI: 3006480587) has 9 FDA import refusal record(s) in our database, spanning from 8/18/2008 to 8/13/2025.
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 3006480587.
What types of violations has Emami Limited received?
Emami Limited 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 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.