SALOMON MALAGON C
✅ Low Risk
FEI: 3004628614 • Cali • COLOMBIA
FEI Number
3004628614
Location
Cali
Country
COLOMBIAAddress
Calle 30 No. 17-1-03, , Cali, , Colombia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is SALOMON MALAGON C's FDA import refusal history?
SALOMON MALAGON C (FEI: 3004628614) has 3 FDA import refusal record(s) in our database, spanning from 10/5/2004 to 10/5/2004.
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. SALOMON MALAGON C's FEI number is 3004628614.
What types of violations has SALOMON MALAGON C received?
SALOMON MALAGON C 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 SALOMON MALAGON C come from?
All FDA import refusal data for SALOMON MALAGON C 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.