Unilever India Export Ltd.
⚠️ Moderate Risk
FEI: 3002574623 • Gandhidham • INDIA
FEI Number
3002574623
Location
Gandhidham
Country
INDIAAddress
Plot 253-257, Sector-Iv, Kandla Special Economic Zone, Gandhidham, , 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).
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.
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).
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2016 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 5/10/2016 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 5/10/2016 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/15/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 6/12/2014 | 61HBY99ANTI-BACTERIAL, N.E.C. | Baltimore District Office (BLT-DO) | |
| 6/12/2014 | 53JG01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 4/30/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 10/26/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/26/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/30/2012 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/9/2011 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 11/4/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 11/4/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 6/5/2009 | 53GC09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/5/2009 | 53GC09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 6/5/2009 | 53GC09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Unilever India Export Ltd.'s FDA import refusal history?
Unilever India Export Ltd. (FEI: 3002574623) has 17 FDA import refusal record(s) in our database, spanning from 6/5/2009 to 12/15/2016.
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. Unilever India Export Ltd.'s FEI number is 3002574623.
What types of violations has Unilever India Export Ltd. received?
Unilever India Export Ltd. has been cited for 10 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 Unilever India Export Ltd. come from?
All FDA import refusal data for Unilever India Export 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.