Emami Limited
⚠️ Moderate Risk
FEI: 3002519116 • Kolkata, West Bengal • INDIA
FEI Number
3002519116
Location
Kolkata, West Bengal
Country
INDIAAddress
18 R N Mukherjee Road, , Kolkata, West Bengal, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 2280DIRSEXMPT | New York District Office (NYK-DO) |
| 8/15/2014 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Southeast Imports (DSEI) | |
| 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) |
| 4/8/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/8/2010 | 66VBL99MISCELLANEOUS 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: 3002519116) has 6 FDA import refusal record(s) in our database, spanning from 4/8/2010 to 2/24/2015.
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 3002519116.
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.