Emami Limited "Epip Complex
⚠️ High Risk
FEI: 3006064602 • Assam • 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
DRUG COLOR
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
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 |
|---|---|---|---|
| 9/30/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/30/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/30/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/16/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/20/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/30/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 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) |
| 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) |
| 9/3/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/15/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 12/15/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 10/13/2023 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/11/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 1/11/2023 | 66YDL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/11/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Northeast Imports (DNEI) | |
| 8/26/2022 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/26/2022 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/15/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 9/15/2014 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 9/15/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/28/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New England District Office (NWE-DO) | |
| 3/28/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New England District Office (NWE-DO) | |
| 3/28/2014 | 63VBJ02HYDROQUINONE (DEPIGMENTOR) | New England District Office (NWE-DO) | |
| 3/4/2014 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 1/25/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 1/25/2013 | 65GBJ99PIGMENTATION AGENT N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/9/2013 | 65GBJ99PIGMENTATION AGENT N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/26/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Emami Limited "Epip Complex's FDA import refusal history?
Emami Limited "Epip Complex (FEI: 3006064602) has 31 FDA import refusal record(s) in our database, spanning from 6/26/2012 to 9/30/2025.
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 "Epip Complex's FEI number is 3006064602.
What types of violations has Emami Limited "Epip Complex received?
Emami Limited "Epip Complex has been cited for 13 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 "Epip Complex come from?
All FDA import refusal data for Emami Limited "Epip Complex 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.