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Kum San Insam Cooperative Association

⚠️ Moderate Risk

FEI: 3004534448 • Kumsangun • SOUTH KOREA

FEI

FEI Number

3004534448

📍

Location

Kumsangun

🇰🇷
🏢

Address

No 162 Jungdori Kumsameup, , Kumsangun, , South Korea

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/4/2004
Latest Refusal
10/20/2004
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

832×

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.

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).

Refusal History

DateProductViolationsDivision
11/4/2004
41CYE99FOODS (INCLUDING WATER) WITH EXCESSIVE NUTRITIONAL CLAIMS
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
10/20/2004
41BYE99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Kum San Insam Cooperative Association's FDA import refusal history?

Kum San Insam Cooperative Association (FEI: 3004534448) has 2 FDA import refusal record(s) in our database, spanning from 10/20/2004 to 11/4/2004.

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. Kum San Insam Cooperative Association's FEI number is 3004534448.

What types of violations has Kum San Insam Cooperative Association received?

Kum San Insam Cooperative Association 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 Kum San Insam Cooperative Association come from?

All FDA import refusal data for Kum San Insam Cooperative Association 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.