Unilever
⚠️ Moderate Risk
FEI: 1000595688 • London • UNITED KINGDOM
FEI Number
1000595688
Location
London
Country
UNITED KINGDOMAddress
Unilever House Blackfriers, , London, , United Kingdom
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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 12/8/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 12/8/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 12/8/2024 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 10/1/2024 | 62MBY08MENTHOL (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 8/30/2024 | 66GBY25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | Division of Southeast Imports (DSEI) | |
| 11/1/2017 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | Division of Northern Border Imports (DNBI) | |
| 11/1/2017 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Unilever's FDA import refusal history?
Unilever (FEI: 1000595688) has 8 FDA import refusal record(s) in our database, spanning from 11/1/2017 to 12/8/2024.
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. Unilever's FEI number is 1000595688.
What types of violations has Unilever received?
Unilever 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 Unilever come from?
All FDA import refusal data for Unilever 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.