LENTES DE CONTACTO VIP ESPANA
⚠️ Moderate Risk
FEI: 3037829788 • Valencia, Valencia • SPAIN
FEI Number
3037829788
Location
Valencia, Valencia
Country
SPAINAddress
Cl Mendizabal 23, , Valencia, Valencia, Spain
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is LENTES DE CONTACTO VIP ESPANA's FDA import refusal history?
LENTES DE CONTACTO VIP ESPANA (FEI: 3037829788) has 1 FDA import refusal record(s) in our database, spanning from 7/15/2025 to 7/15/2025.
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. LENTES DE CONTACTO VIP ESPANA's FEI number is 3037829788.
What types of violations has LENTES DE CONTACTO VIP ESPANA received?
LENTES DE CONTACTO VIP ESPANA has been cited for 4 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 LENTES DE CONTACTO VIP ESPANA come from?
All FDA import refusal data for LENTES DE CONTACTO VIP ESPANA 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.