Emami Limited
⚠️ High Risk
FEI: 3008611461 • Pantnagar, West Bengal • INDIA
FEI Number
3008611461
Location
Pantnagar, West Bengal
Country
INDIAAddress
Plot No. 40-41, Sector 5, Pantnagar, 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).
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.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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 |
|---|---|---|---|
| 11/25/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/26/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/26/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/15/2022 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/26/2022 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southwest Imports (DSWI) | |
| 7/27/2021 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/7/2020 | 66VCO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/26/2017 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 5/25/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2016 | 60LBJ99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/15/2016 | 53CC03EYE SHADOW (EYE MAKEUP PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 2/12/2016 | 54FEJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/12/2016 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/12/2016 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/21/2010 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) | |
| 12/21/2010 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) | |
| 12/9/2010 | 62MDJ08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Emami Limited's FDA import refusal history?
Emami Limited (FEI: 3008611461) has 19 FDA import refusal record(s) in our database, spanning from 12/9/2010 to 11/25/2024.
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. Emami Limited's FEI number is 3008611461.
What types of violations has Emami Limited received?
Emami Limited has been cited for 11 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.