Unilever, home and personal care, UK
⚠️ Moderate Risk
FEI: 3009970974 • Kingston Upon Thames, Surrey • UNITED KINGDOM
FEI Number
3009970974
Location
Kingston Upon Thames, Surrey
Country
UNITED KINGDOMAddress
3 St. James Road, , Kingston Upon Thames, Surrey, 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).
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).
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.
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.
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.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/3/2022 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/1/2018 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 62WBL16ALUM (ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 62WBL16ALUM (ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 62WBL16ALUM (ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 2/22/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Unilever, home and personal care, UK's FDA import refusal history?
Unilever, home and personal care, UK (FEI: 3009970974) has 7 FDA import refusal record(s) in our database, spanning from 2/22/2013 to 3/3/2022.
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, home and personal care, UK's FEI number is 3009970974.
What types of violations has Unilever, home and personal care, UK received?
Unilever, home and personal care, UK has been cited for 8 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, home and personal care, UK come from?
All FDA import refusal data for Unilever, home and personal care, UK 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.