Energy Cosmetic
⚠️ Moderate Risk
FEI: 3006706421 • Lominaki • POLAND
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2008 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 3/18/2008 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 3/18/2008 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 3/18/2008 | 65LBJ99PROTECTANT N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Energy Cosmetic's FDA import refusal history?
Energy Cosmetic (FEI: 3006706421) has 4 FDA import refusal record(s) in our database, spanning from 3/18/2008 to 3/18/2008.
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. Energy Cosmetic's FEI number is 3006706421.
What types of violations has Energy Cosmetic received?
Energy Cosmetic has been cited for 2 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 Energy Cosmetic come from?
All FDA import refusal data for Energy Cosmetic 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.