ImportRefusal LogoImportRefusal

INVET S.A.

⚠️ Moderate Risk

FEI: 3014316091 • Entrada Parcela Bod 1 • COLOMBIA

FEI

FEI Number

3014316091

📍

Location

Entrada Parcela Bod 1

🇨🇴

Country

COLOMBIA
🏢

Address

Autopista Medellin Km 2, , Entrada Parcela Bod 1, , Colombia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/20/2018
Latest Refusal
4/20/2018
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
4/20/2018
56DPL20GENTAMICIN (AMINOGLYCOSIDES)
72NEW VET DR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INVET S.A.'s FDA import refusal history?

INVET S.A. (FEI: 3014316091) has 1 FDA import refusal record(s) in our database, spanning from 4/20/2018 to 4/20/2018.

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. INVET S.A.'s FEI number is 3014316091.

What types of violations has INVET S.A. received?

INVET S.A. 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 INVET S.A. come from?

All FDA import refusal data for INVET S.A. 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.