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LABORATORIOS MICROSULES URUGUAY

⚠️ Moderate Risk

FEI: 3017009429 • Canelones • URUGUAY

FEI

FEI Number

3017009429

📍

Location

Canelones

🇺🇾

Country

URUGUAY
🏢

Address

Ruta 101 Km 28camino Alpaso Escobar, , Canelones, , Uruguay

Moderate Risk

FDA Import Risk Assessment

38.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/21/2023
Latest Refusal
6/21/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
48.8×20%
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

39011×

VET DR LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of Section 502(w) of the FD&C Act in that it appears to be a new animal drug ?

Refusal History

DateProductViolationsDivision
6/21/2023
70YY99ANIMAL FEEDS, N.E.C.
3901VET DR LBL
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is LABORATORIOS MICROSULES URUGUAY's FDA import refusal history?

LABORATORIOS MICROSULES URUGUAY (FEI: 3017009429) has 1 FDA import refusal record(s) in our database, spanning from 6/21/2023 to 6/21/2023.

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 MICROSULES URUGUAY's FEI number is 3017009429.

What types of violations has LABORATORIOS MICROSULES URUGUAY received?

LABORATORIOS MICROSULES URUGUAY 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 MICROSULES URUGUAY come from?

All FDA import refusal data for LABORATORIOS MICROSULES URUGUAY 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.