LILIANA FUENTES GIRALDO
⚠️ Moderate Risk
FEI: 3014107141 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3014107141
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Cra 28 Transv 30 - 20 Bparais, , Cali, Valle Del Cauca, Colombia
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2018 | 62GAC41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 62OCC20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 62OCC41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2018 | 62OCC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LILIANA FUENTES GIRALDO's FDA import refusal history?
LILIANA FUENTES GIRALDO (FEI: 3014107141) has 5 FDA import refusal record(s) in our database, spanning from 1/3/2018 to 1/3/2018.
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. LILIANA FUENTES GIRALDO's FEI number is 3014107141.
What types of violations has LILIANA FUENTES GIRALDO received?
LILIANA FUENTES GIRALDO 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 LILIANA FUENTES GIRALDO come from?
All FDA import refusal data for LILIANA FUENTES GIRALDO 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.