SESDERMA SL
⚠️ High Risk
FEI: 3019984236 • Pucol, Valencia • SPAIN
FEI Number
3019984236
Location
Pucol, Valencia
Country
SPAINAddress
Pol Industrial La Murta, Avinguda Molins 12, Pucol, Valencia, Spain
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 |
|---|---|---|---|
| 11/13/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 8/25/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/26/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SESDERMA SL's FDA import refusal history?
SESDERMA SL (FEI: 3019984236) has 4 FDA import refusal record(s) in our database, spanning from 7/26/2025 to 11/13/2025.
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. SESDERMA SL's FEI number is 3019984236.
What types of violations has SESDERMA SL received?
SESDERMA SL 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 SESDERMA SL come from?
All FDA import refusal data for SESDERMA SL 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.