MARTIDERM SL
⚠️ High Risk
FEI: 3013273628 • Cervello, Barcelona • SPAIN
FEI Number
3013273628
Location
Cervello, Barcelona
Country
SPAINAddress
Calle Garnatxa 20-22, , Cervello, Barcelona, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2024 | 66PBJ14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Northern Border Imports (DNBI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is MARTIDERM SL's FDA import refusal history?
MARTIDERM SL (FEI: 3013273628) has 8 FDA import refusal record(s) in our database, spanning from 3/26/2018 to 7/26/2024.
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. MARTIDERM SL's FEI number is 3013273628.
What types of violations has MARTIDERM SL received?
MARTIDERM SL has been cited for 3 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 MARTIDERM SL come from?
All FDA import refusal data for MARTIDERM 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.