Kenvue Brands LLC
⚠️ Moderate Risk
FEI: 2510770 • Lititz, PA • UNITED STATES
FEI Number
2510770
Location
Lititz, PA
Country
UNITED STATESAddress
400 W Lincoln Ave, , Lititz, PA, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
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.
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 |
|---|---|---|---|
| 9/2/2003 | 64AAY99DISINFECTANT N.E.C. | 336INCONSPICU | New York District Office (NYK-DO) |
| 9/2/2003 | 64AAY99DISINFECTANT N.E.C. | 336INCONSPICU | New York District Office (NYK-DO) |
| 9/2/2003 | 64AAY99DISINFECTANT N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/5/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/5/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 10/5/2001 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Kenvue Brands LLC's FDA import refusal history?
Kenvue Brands LLC (FEI: 2510770) has 6 FDA import refusal record(s) in our database, spanning from 10/5/2001 to 9/2/2003.
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 2510770.
What types of violations has Kenvue Brands LLC received?
Kenvue Brands LLC has been cited for 5 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.