ImportRefusal LogoImportRefusal

Otoki Corporation Daepoong Factory

⚠️ Moderate Risk

FEI: 3009934446 • Umseong-gun, CHUNGBUK • SOUTH KOREA

FEI

FEI Number

3009934446

📍

Location

Umseong-gun, CHUNGBUK

🇰🇷
🏢

Address

128,Daepoongsandan-ro, Daeso-Myun, , Umseong-gun, CHUNGBUK, South Korea

Moderate Risk

FDA Import Risk Assessment

44.3
LowModerateHighCritical

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

Statistics

9
Total Refusals
2
Unique Violations
8/28/2019
Latest Refusal
4/3/2012
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
12.2×10%
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

837×

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.

622×

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
8/28/2019
16AVE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
83NO PROCESS
Division of West Coast Imports (DWCI)
8/28/2019
02DHE02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
83NO PROCESS
Division of West Coast Imports (DWCI)
8/28/2019
02DHE02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
83NO PROCESS
Division of West Coast Imports (DWCI)
7/10/2018
02DHE02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
83NO PROCESS
Division of Northeast Imports (DNEI)
7/17/2013
37JDE16BEAN, BLACK SAUCE
83NO PROCESS
San Francisco District Office (SAN-DO)
4/8/2013
37JDE99SAUCES, N.E.C.
62NEEDS FCE
Seattle District Office (SEA-DO)
4/8/2013
37JDE16BEAN, BLACK SAUCE
62NEEDS FCE
Seattle District Office (SEA-DO)
4/3/2012
02DHE02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
83NO PROCESS
New York District Office (NYK-DO)
4/3/2012
02DHE02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Otoki Corporation Daepoong Factory's FDA import refusal history?

Otoki Corporation Daepoong Factory (FEI: 3009934446) has 9 FDA import refusal record(s) in our database, spanning from 4/3/2012 to 8/28/2019.

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. Otoki Corporation Daepoong Factory's FEI number is 3009934446.

What types of violations has Otoki Corporation Daepoong Factory received?

Otoki Corporation Daepoong Factory 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 Otoki Corporation Daepoong Factory come from?

All FDA import refusal data for Otoki Corporation Daepoong Factory 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.