ImportRefusal LogoImportRefusal

JESSICA TOVAR

⚠️ High Risk

FEI: 3014158390 • Bogota, Cundinamarca • COLOMBIA

FEI

FEI Number

3014158390

📍

Location

Bogota, Cundinamarca

🇨🇴

Country

COLOMBIA
🏢

Address

Francisco Chia, Cra 2 No 16 171 Barriosan, Bogota, Cundinamarca, Colombia

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
2/26/2018
Latest Refusal
2/26/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

757×

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
2/26/2018
60SCA28RANITIDINE (ANTACID)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/26/2018
64BCB37SPIRONOLACTONE (DIURETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/26/2018
62OCB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/26/2018
61JCB11GEMFIBROZIL (ANTI-CHOLESTEREMIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/26/2018
62OCB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/26/2018
61LCB99ANTI-COAGULANT, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/26/2018
63ECB28PROPAFENONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JESSICA TOVAR's FDA import refusal history?

JESSICA TOVAR (FEI: 3014158390) has 7 FDA import refusal record(s) in our database, spanning from 2/26/2018 to 2/26/2018.

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. JESSICA TOVAR's FEI number is 3014158390.

What types of violations has JESSICA TOVAR received?

JESSICA TOVAR 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 JESSICA TOVAR come from?

All FDA import refusal data for JESSICA TOVAR 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.