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ANA ISABEL VEDOYA LIZARAZO

⚠️ High Risk

FEI: 3014476301 • Bogota, Cundinamarca • COLOMBIA

FEI

FEI Number

3014476301

📍

Location

Bogota, Cundinamarca

🇨🇴

Country

COLOMBIA
🏢

Address

Cll 10 No 4 50 Brr Alianza, , Bogota, Cundinamarca, Colombia

High Risk

FDA Import Risk Assessment

58.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

11
Total Refusals
1
Unique Violations
7/18/2018
Latest Refusal
7/18/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7511×

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

DateProductViolationsDivision
7/18/2018
60LCB14CARBAMAZEPINE (ANALGESIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
61PCB26METFORMIN (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
66NCB07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
66NCB02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
61LCB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
60XCB17ATENOLOL (ANTI-ADRENERGIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
61NCB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
61NCB73MIRTAZAPINE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
62OCB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/18/2018
66NCB04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ANA ISABEL VEDOYA LIZARAZO's FDA import refusal history?

ANA ISABEL VEDOYA LIZARAZO (FEI: 3014476301) has 11 FDA import refusal record(s) in our database, spanning from 7/18/2018 to 7/18/2018.

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. ANA ISABEL VEDOYA LIZARAZO's FEI number is 3014476301.

What types of violations has ANA ISABEL VEDOYA LIZARAZO received?

ANA ISABEL VEDOYA LIZARAZO 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 ANA ISABEL VEDOYA LIZARAZO come from?

All FDA import refusal data for ANA ISABEL VEDOYA LIZARAZO 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.