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Sung Shin Bst Co Ltd

⚠️ Moderate Risk

FEI: 3010585929 • Geumsan • SOUTH KOREA

FEI

FEI Number

3010585929

📍

Location

Geumsan

🇰🇷
🏢

Address

981 Junak Ro Geumsan Eup, , Geumsan, , South Korea

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/13/2019
Latest Refusal
5/13/2019
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

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
5/13/2019
54FCK12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Sung Shin Bst Co Ltd's FDA import refusal history?

Sung Shin Bst Co Ltd (FEI: 3010585929) has 1 FDA import refusal record(s) in our database, spanning from 5/13/2019 to 5/13/2019.

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. Sung Shin Bst Co Ltd's FEI number is 3010585929.

What types of violations has Sung Shin Bst Co Ltd received?

Sung Shin Bst Co Ltd has been cited for 2 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 Sung Shin Bst Co Ltd come from?

All FDA import refusal data for Sung Shin Bst 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.