CLINICA SANTA LUCIA
⚠️ Moderate Risk
FEI: 3016928657 • Quito, Pichincha • ECUADOR
FEI Number
3016928657
Location
Quito, Pichincha
Country
ECUADORAddress
Suiza And Eloy Alfa 209, , Quito, Pichincha, Ecuador
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).
Refusal History
Frequently Asked Questions
What is CLINICA SANTA LUCIA's FDA import refusal history?
CLINICA SANTA LUCIA (FEI: 3016928657) has 2 FDA import refusal record(s) in our database, spanning from 6/25/2020 to 6/25/2020.
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. CLINICA SANTA LUCIA's FEI number is 3016928657.
What types of violations has CLINICA SANTA LUCIA received?
CLINICA SANTA LUCIA 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 CLINICA SANTA LUCIA come from?
All FDA import refusal data for CLINICA SANTA LUCIA 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.