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DONGWON F&B KWANGJU PLANT

⚠️ Moderate Risk

FEI: 3003418474 • Kwangju, KWANGJU • SOUTH KOREA

FEI

FEI Number

3003418474

📍

Location

Kwangju, KWANGJU

🇰🇷
🏢

Address

734-1 ANCHUNGDONG, KWANGSANGU, , Kwangju, KWANGJU, South Korea

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/12/2005
Latest Refusal
10/12/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

623×

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).

833×

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
10/12/2005
29AET99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
10/12/2005
29AET99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
10/12/2005
29AET99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is DONGWON F&B KWANGJU PLANT's FDA import refusal history?

DONGWON F&B KWANGJU PLANT (FEI: 3003418474) has 3 FDA import refusal record(s) in our database, spanning from 10/12/2005 to 10/12/2005.

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. DONGWON F&B KWANGJU PLANT's FEI number is 3003418474.

What types of violations has DONGWON F&B KWANGJU PLANT received?

DONGWON F&B KWANGJU PLANT 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 DONGWON F&B KWANGJU PLANT come from?

All FDA import refusal data for DONGWON F&B KWANGJU PLANT 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.