Hindustan Lever Ltd.
⚠️ Moderate Risk
FEI: 3004356927 • Mumbai, Tinsukia District • INDIA
FEI Number
3004356927
Location
Mumbai, Tinsukia District
Country
INDIAAddress
Dag No.21 Of 122 F.s.grant, Mouza-tingra, Doomdooma Industrial Estate, Off Nh-37, Mumbai, Tinsukia District, 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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
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 |
|---|---|---|---|
| 7/10/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/28/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 4/4/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/21/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/21/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/9/2012 | 53L03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 10/24/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 1/19/2008 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 1/19/2008 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 1/19/2008 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/14/2007 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 2/7/2007 | 63VBJ99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/7/2007 | 63VBJ99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/7/2007 | 63VBJ99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/4/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/4/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/6/2006 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 7/6/2006 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 3/27/2006 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/6/2005 | 65GBJ99PIGMENTATION AGENT N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 12/6/2005 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/6/2005 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/12/2005 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/15/2005 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/26/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/7/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hindustan Lever Ltd.'s FDA import refusal history?
Hindustan Lever Ltd. (FEI: 3004356927) has 26 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 7/10/2014.
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. Hindustan Lever Ltd.'s FEI number is 3004356927.
What types of violations has Hindustan Lever Ltd. received?
Hindustan Lever Ltd. has been cited for 6 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 Hindustan Lever Ltd. come from?
All FDA import refusal data for Hindustan Lever Ltd. 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.