Kenvue Brands LLC
⚠️ Moderate Risk
FEI: 2214133 • Summit, NJ • UNITED STATES
FEI Number
2214133
Location
Summit, NJ
Country
UNITED STATESAddress
1 Kenvue Way, , Summit, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2025 | 65FBL06WATER, PURIFIED (EYEWASH) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/17/2023 | 80FQMBANDAGE, ELASTIC | Division of Southeast Imports (DSEI) | |
| 7/26/2022 | 76LBHVARNISH, CAVITY | Division of Southeast Imports (DSEI) | |
| 8/10/2010 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 8/10/2010 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Detroit District Office (DET-DO) |
| 11/26/2001 | 79FRODRESSING, WOUND, DRUG | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Kenvue Brands LLC's FDA import refusal history?
Kenvue Brands LLC (FEI: 2214133) has 6 FDA import refusal record(s) in our database, spanning from 11/26/2001 to 11/21/2025.
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. Kenvue Brands LLC's FEI number is 2214133.
What types of violations has Kenvue Brands LLC received?
Kenvue Brands LLC has been cited for 3 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 Kenvue Brands LLC come from?
All FDA import refusal data for Kenvue Brands 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.