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Exportadora Subsole SA Planta Isla de Maipo

⚠️ High Risk

FEI: 2000009479 • Isla de Maipo, Region Metropolitana de Santia • CHILE

FEI

FEI Number

2000009479

📍

Location

Isla de Maipo, Region Metropolitana de Santia

🇨🇱

Country

CHILE
🏢

Address

Balmaceda 6475, , Isla de Maipo, Region Metropolitana de Santia, Chile

High Risk

FDA Import Risk Assessment

69.4
LowModerateHighCritical

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

Statistics

19
Total Refusals
5
Unique Violations
3/8/2024
Latest Refusal
2/22/2019
Earliest Refusal

Score Breakdown

Violation Severity
96.3×40%
Refusal Volume
48.2×30%
Recency
63.1×20%
Frequency
37.7×10%
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

29515×

LISTERIA

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

3066×

INSANITARY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

2512×

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:

3082×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

38212×

MFR INJ

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/8/2024
21GFC07NECTARINE (PIT FRUIT)
251POISONOUS
Division of Northeast Imports (DNEI)
3/6/2024
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
3/6/2024
21GFC07NECTARINE (PIT FRUIT)
251POISONOUS
Division of Northeast Imports (DNEI)
2/23/2024
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
6/1/2021
21GFC07NECTARINE (PIT FRUIT)
308MFR INSAN
3821MFR INJ
Division of Northeast Imports (DNEI)
5/20/2021
21GFC07NECTARINE (PIT FRUIT)
308MFR INSAN
3821MFR INJ
Division of Northeast Imports (DNEI)
3/21/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
306INSANITARY
Division of West Coast Imports (DWCI)
3/21/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
306INSANITARY
Division of West Coast Imports (DWCI)
3/21/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
306INSANITARY
Division of West Coast Imports (DWCI)
3/21/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
306INSANITARY
Division of West Coast Imports (DWCI)
3/21/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
306INSANITARY
Division of West Coast Imports (DWCI)
3/21/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
306INSANITARY
Division of West Coast Imports (DWCI)
3/19/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
2/22/2019
21GFC14PLUM (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
2/22/2019
21GFC13PEACH (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
2/22/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
2/22/2019
21GFC14PLUM (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
2/22/2019
21GFC13PEACH (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)
2/22/2019
21GFC07NECTARINE (PIT FRUIT)
295LISTERIA
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Exportadora Subsole SA Planta Isla de Maipo's FDA import refusal history?

Exportadora Subsole SA Planta Isla de Maipo (FEI: 2000009479) has 19 FDA import refusal record(s) in our database, spanning from 2/22/2019 to 3/8/2024.

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. Exportadora Subsole SA Planta Isla de Maipo's FEI number is 2000009479.

What types of violations has Exportadora Subsole SA Planta Isla de Maipo received?

Exportadora Subsole SA Planta Isla de Maipo has been cited for 5 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 Exportadora Subsole SA Planta Isla de Maipo come from?

All FDA import refusal data for Exportadora Subsole SA Planta Isla de Maipo 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.