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SEOUL WONYE NONGHYUP

⚠️ Moderate Risk

FEI: 3012201141 • Namyangju • SOUTH KOREA

FEI

FEI Number

3012201141

📍

Location

Namyangju

🇰🇷
🏢

Address

70-3 Toegyewon-Ri, Toeg, Yewon-myeon, Namyangju, , 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
6/28/2016
Latest Refusal
6/28/2016
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
6/28/2016
29AHT99NONCARBONATED SOFT DRINK, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is SEOUL WONYE NONGHYUP's FDA import refusal history?

SEOUL WONYE NONGHYUP (FEI: 3012201141) has 1 FDA import refusal record(s) in our database, spanning from 6/28/2016 to 6/28/2016.

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. SEOUL WONYE NONGHYUP's FEI number is 3012201141.

What types of violations has SEOUL WONYE NONGHYUP received?

SEOUL WONYE NONGHYUP 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 SEOUL WONYE NONGHYUP come from?

All FDA import refusal data for SEOUL WONYE NONGHYUP 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.