KENVUE ITALIA S.P.A
⚠️ High Risk
FEI: 1000313732 • Pomezia, Rome • ITALY
FEI Number
1000313732
Location
Pomezia, Rome
Country
ITALYAddress
Via Ardeatina Km. 23.5, Santa Palomba, Pomezia, Rome, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2025 | 64ABL99DISINFECTANT N.E.C. | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 9/23/2025 | 64ABL99DISINFECTANT N.E.C. | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 9/23/2025 | 64ABL99DISINFECTANT N.E.C. | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 7/22/2025 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/1/2024 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Northeast Imports (DNEI) | |
| 8/30/2024 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) | |
| 6/25/2024 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) | |
| 6/25/2024 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) | |
| 5/23/2024 | 76LBHVARNISH, CAVITY | Division of Southeast Imports (DSEI) | |
| 9/24/2021 | 64ABL99DISINFECTANT N.E.C. | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 4/14/2017 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) | |
| 4/14/2017 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) | |
| 4/14/2017 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is KENVUE ITALIA S.P.A's FDA import refusal history?
KENVUE ITALIA S.P.A (FEI: 1000313732) has 13 FDA import refusal record(s) in our database, spanning from 4/14/2017 to 9/23/2025.
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 ITALIA S.P.A's FEI number is 1000313732.
What types of violations has KENVUE ITALIA S.P.A received?
KENVUE ITALIA S.P.A has been cited for 6 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 ITALIA S.P.A come from?
All FDA import refusal data for KENVUE ITALIA S.P.A 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.