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Fruselva America SPA

🚨 Critical Risk

FEI: 3010485191 β€’ Maule, Region del Maule β€’ CHILE

FEI

FEI Number

3010485191

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Location

Maule, Region del Maule

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Country

CHILE
🏒

Address

Longitudinal Sur Km 264, , Maule, Region del Maule, Chile

Critical Risk

FDA Import Risk Assessment

77.0
LowModerateHighCritical

This firm has an extensive history of FDA import refusals with severe violations.

Statistics

18
Total Refusals
3
Unique Violations
8/27/2025
Latest Refusal
9/7/2022
Earliest Refusal

Score Breakdown

Violation Severity
95.6Γ—40%
Refusal Volume
47.4Γ—30%
Recency
92.5Γ—20%
Frequency
60.5Γ—10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity β€” AI-assessed (1-10)
  • 30% Refusal Volume β€” Logarithmic scale
  • 20% Recency β€” Decays over 5 years
  • 10% Frequency β€” Refusals per year

Β© ImportRefusal.com Original Analysis

Violation Summary

2497Γ—

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

2517Γ—

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

34004Γ—

PB-FOOD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.

Refusal History

DateProductViolationsDivision
8/27/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
8/27/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
6/3/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
6/3/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
6/3/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
6/3/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
6/3/2025
40YGN99BABY AND JUNIOR FOOD N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
3400PB-FOOD
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
3400PB-FOOD
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
3400PB-FOOD
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Southwest Imports (DSWI)
11/17/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Southwest Imports (DSWI)
1/6/2023
40YGN99BABY AND JUNIOR FOOD N.E.C.
251POISONOUS
Division of Northeast Imports (DNEI)
9/7/2022
40YGN99BABY AND JUNIOR FOOD N.E.C.
3400PB-FOOD
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Fruselva America SPA's FDA import refusal history?

Fruselva America SPA (FEI: 3010485191) has 18 FDA import refusal record(s) in our database, spanning from 9/7/2022 to 8/27/2025.

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. Fruselva America SPA's FEI number is 3010485191.

What types of violations has Fruselva America SPA received?

Fruselva America SPA has been cited for 3 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 Fruselva America SPA come from?

All FDA import refusal data for Fruselva America SPA 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.