Kenvue Brands LLC
⚠️ Moderate Risk
FEI: 2510184 • Fort Washington, PA • UNITED STATES
FEI Number
2510184
Location
Fort Washington, PA
Country
UNITED STATESAddress
7050 Camp Hill Rd, , Fort Washington, 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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 12/13/2011 | 62UBK11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/15/2009 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/15/2009 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/15/2009 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/8/2007 | 61CIB99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2006 | 60LAS05ASPIRIN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/20/2006 | 60LCL01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/20/2006 | 60LAE01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2006 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2006 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/18/2006 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/7/2005 | 60LAK01ACETAMINOPHEN (ANALGESIC) | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 8/24/2004 | 60LBF01ACETAMINOPHEN (ANALGESIC) | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 4/23/2004 | 60LBA05ASPIRIN (ANALGESIC) | New York District Office (NYK-DO) | |
| 7/19/2002 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/19/2002 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/19/2002 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/19/2002 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/19/2002 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/19/2002 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Kenvue Brands LLC's FDA import refusal history?
Kenvue Brands LLC (FEI: 2510184) has 20 FDA import refusal record(s) in our database, spanning from 7/19/2002 to 12/13/2011.
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 2510184.
What types of violations has Kenvue Brands LLC received?
Kenvue Brands LLC 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 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.