7SKIN LDA
⚠️ High Risk
FEI: 3018448190 • Porto, Porto • PORTUGAL
FEI Number
3018448190
Location
Porto, Porto
Country
PORTUGALAddress
Rua 5 De Outubro 359, , Porto, Porto, Portugal
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2025 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/30/2025 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/30/2025 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/30/2025 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 7/31/2025 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is 7SKIN LDA's FDA import refusal history?
7SKIN LDA (FEI: 3018448190) has 5 FDA import refusal record(s) in our database, spanning from 7/31/2025 to 10/30/2025.
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. 7SKIN LDA's FEI number is 3018448190.
What types of violations has 7SKIN LDA received?
7SKIN LDA 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 7SKIN LDA come from?
All FDA import refusal data for 7SKIN LDA 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.