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Sunstar Inc

⚠️ Moderate Risk

FEI: 3010574308 • Itano-Gun, Tokushima • JAPAN

FEI

FEI Number

3010574308

📍

Location

Itano-Gun, Tokushima

🇯🇵

Country

JAPAN
🏢

Address

Toyohisa Qc Dept Tokushima Pl Ant 139-16, Hiroshima; Matsushige-Cho, Itano-Gun, Tokushima, Japan

Moderate Risk

FDA Import Risk Assessment

33.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
9/3/2019
Latest Refusal
9/3/2019
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

4737×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
9/3/2019
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)
9/3/2019
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)
9/3/2019
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)
9/3/2019
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)
9/3/2019
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)
9/3/2019
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)
9/3/2019
53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sunstar Inc's FDA import refusal history?

Sunstar Inc (FEI: 3010574308) has 7 FDA import refusal record(s) in our database, spanning from 9/3/2019 to 9/3/2019.

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. Sunstar Inc's FEI number is 3010574308.

What types of violations has Sunstar Inc received?

Sunstar Inc 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 Sunstar Inc come from?

All FDA import refusal data for Sunstar Inc 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.