Unilever North America Supply Chain Company, LLC
⚠️ Moderate Risk
FEI: 3011085131 • Englewood Cliffs, NJ • UNITED STATES
FEI Number
3011085131
Location
Englewood Cliffs, NJ
Country
UNITED STATESAddress
700 Sylvan Ave, , Englewood Cliffs, NJ, United States
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.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
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.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2025 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/15/2015 | 64XBJ99KERATOLYTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 3/1/2012 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | Florida District Office (FLA-DO) | |
| 2/7/2005 | 28BHE04BASIL (SWEET BASIL), GROUND, CRACKED (SPICE) | 260FALSE | New York District Office (NYK-DO) |
| 9/12/2003 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/27/2003 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 2/13/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Unilever North America Supply Chain Company, LLC's FDA import refusal history?
Unilever North America Supply Chain Company, LLC (FEI: 3011085131) has 7 FDA import refusal record(s) in our database, spanning from 2/13/2003 to 12/22/2025.
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. Unilever North America Supply Chain Company, LLC's FEI number is 3011085131.
What types of violations has Unilever North America Supply Chain Company, LLC received?
Unilever North America Supply Chain Company, LLC has been cited for 12 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 North America Supply Chain Company, LLC come from?
All FDA import refusal data for Unilever North America Supply Chain Company, LLC 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.