Lumene Oy
⚠️ High Risk
FEI: 3003908435 • Espoo, Uusimaa • FINLAND
FEI Number
3003908435
Location
Espoo, Uusimaa
Country
FINLANDAddress
Lasikuja 2, , Espoo, Uusimaa, Finland
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/23/2024 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 6/2/2024 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 1/17/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/3/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/15/2023 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Lumene Oy's FDA import refusal history?
Lumene Oy (FEI: 3003908435) has 6 FDA import refusal record(s) in our database, spanning from 3/15/2023 to 3/21/2025.
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. Lumene Oy's FEI number is 3003908435.
What types of violations has Lumene Oy received?
Lumene Oy has been cited for 1 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 Lumene Oy come from?
All FDA import refusal data for Lumene Oy 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.