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Shinseon F&V Co. Ltd.

⚠️ High Risk

FEI: 3012836712 • Sancheong, Gyeongsangnam • SOUTH KOREA

FEI

FEI Number

3012836712

📍

Location

Sancheong, Gyeongsangnam

🇰🇷
🏢

Address

2462-14 Chinhwangyeong-Ro, Geumseo-Myeon, Sancheong, Gyeongsangnam, South Korea

High Risk

FDA Import Risk Assessment

50.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/21/2024
Latest Refusal
6/21/2024
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
68.5×20%
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

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
6/21/2024
24AEE07KIDNEY BEAN
83NO PROCESS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Shinseon F&V Co. Ltd.'s FDA import refusal history?

Shinseon F&V Co. Ltd. (FEI: 3012836712) has 1 FDA import refusal record(s) in our database, spanning from 6/21/2024 to 6/21/2024.

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. Shinseon F&V Co. Ltd.'s FEI number is 3012836712.

What types of violations has Shinseon F&V Co. Ltd. received?

Shinseon F&V Co. Ltd. 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 Shinseon F&V Co. Ltd. come from?

All FDA import refusal data for Shinseon F&V Co. Ltd. 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.