Arisma Ltda
✅ Low Risk
FEI: 3004099224 • Santafe De Bogota • COLOMBIA
FEI Number
3004099224
Location
Santafe De Bogota
Country
COLOMBIAAddress
Carrera 15 No 52-28, , Santafe De Bogota, , 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2003 | 80FLKTHERMOMETER, CLINICAL MERCURY | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Arisma Ltda's FDA import refusal history?
Arisma Ltda (FEI: 3004099224) has 1 FDA import refusal record(s) in our database, spanning from 9/24/2003 to 9/24/2003.
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. Arisma Ltda's FEI number is 3004099224.
What types of violations has Arisma Ltda received?
Arisma Ltda 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 Arisma Ltda come from?
All FDA import refusal data for Arisma Ltda 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.