ALEXANDER TRUJILLO PANTEVEZ
⚠️ High Risk
FEI: 3015287607 • Neiva, Huila • COLOMBIA
FEI Number
3015287607
Location
Neiva, Huila
Country
COLOMBIAAddress
Carrera 5 No. 9 - 36 Sur, , Neiva, Huila, Colombia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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 |
|---|---|---|---|
| 5/10/2019 | 61PDL54LISPRO INSULIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 61PDL54LISPRO INSULIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 60LDY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 64BDY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 62KDY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 62ODY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 66SDY46CILOSTAZOL (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 63XDY83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 61LDY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 63FDY06DIGOXIN (CARDIOTONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ALEXANDER TRUJILLO PANTEVEZ's FDA import refusal history?
ALEXANDER TRUJILLO PANTEVEZ (FEI: 3015287607) has 12 FDA import refusal record(s) in our database, spanning from 5/10/2019 to 5/10/2019.
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. ALEXANDER TRUJILLO PANTEVEZ's FEI number is 3015287607.
What types of violations has ALEXANDER TRUJILLO PANTEVEZ received?
ALEXANDER TRUJILLO PANTEVEZ 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 ALEXANDER TRUJILLO PANTEVEZ come from?
All FDA import refusal data for ALEXANDER TRUJILLO PANTEVEZ 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.