ImportRefusal LogoImportRefusal

Laboratorios Invesbio Srl

⚠️ Moderate Risk

FEI: 3009014024 • Buenos Aires • ARGENTINA

FEI

FEI Number

3009014024

📍

Location

Buenos Aires

🇦🇷

Country

ARGENTINA
🏢

Address

Florentino Ameghino 1159, , Buenos Aires, , Argentina

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/26/2011
Latest Refusal
9/26/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

723×

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
9/26/2011
56DKL41NEOMYCIN SULFATE (AMINOGLYCOSIDES)
72NEW VET DR
New Orleans District Office (NOL-DO)
9/26/2011
64BRL24FUROSEMIDE (DIURETIC)
72NEW VET DR
New Orleans District Office (NOL-DO)
9/26/2011
68HDL20PARASITICIDES (EXTERNAL) USED MORE THAN 1 SPECIES
72NEW VET DR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratorios Invesbio Srl's FDA import refusal history?

Laboratorios Invesbio Srl (FEI: 3009014024) has 3 FDA import refusal record(s) in our database, spanning from 9/26/2011 to 9/26/2011.

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. Laboratorios Invesbio Srl's FEI number is 3009014024.

What types of violations has Laboratorios Invesbio Srl received?

Laboratorios Invesbio Srl 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 Laboratorios Invesbio Srl come from?

All FDA import refusal data for Laboratorios Invesbio Srl 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.