Energizer Personal Care
⚠️ Moderate Risk
FEI: 3008367733 • Allendale, NJ • UNITED STATES
FEI Number
3008367733
Location
Allendale, NJ
Country
UNITED STATESAddress
75 Commerce Dr, , Allendale, 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) in that it is a device whose labeling appears to be false or misleading.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2018 | 85HHDPAD, MENSTRUAL, UNSCENTED | Division of Northeast Imports (DNEI) | |
| 8/6/2018 | 85HHDPAD, MENSTRUAL, UNSCENTED | Division of Northeast Imports (DNEI) | |
| 5/26/2016 | 66PBQ05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Energizer Personal Care's FDA import refusal history?
Energizer Personal Care (FEI: 3008367733) has 3 FDA import refusal record(s) in our database, spanning from 5/26/2016 to 8/6/2018.
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. Energizer Personal Care's FEI number is 3008367733.
What types of violations has Energizer Personal Care received?
Energizer Personal Care 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 Energizer Personal Care come from?
All FDA import refusal data for Energizer Personal Care 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.