Emami Limited
⚠️ High Risk
FEI: 3008843383 • Thane, Maharashtra • INDIA
FEI Number
3008843383
Location
Thane, Maharashtra
Country
INDIAAddress
Plot No. 200, Talasari Sanjan Amgaon Road, Village Dongari, Thane, Maharashtra, 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).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2025 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 10/13/2023 | 54YGJ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/21/2021 | 62MCY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/28/2014 | 62MBJ08MENTHOL (ANTI-PRURITIC) | New England District Office (NWE-DO) | |
| 9/21/2012 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/21/2012 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/26/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Emami Limited's FDA import refusal history?
Emami Limited (FEI: 3008843383) has 7 FDA import refusal record(s) in our database, spanning from 5/26/2011 to 5/29/2025.
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 3008843383.
What types of violations has Emami Limited received?
Emami Limited has been cited for 4 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.