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The Ocean Co Ltd

⚠️ High Risk

FEI: 3009807821 • Incheon, Incheon • SOUTH KOREA

FEI

FEI Number

3009807821

📍

Location

Incheon, Incheon

🇰🇷
🏢

Address

54 Wanjeongro, 2-Gil, Seo-Gu, , Incheon, Incheon, South Korea

High Risk

FDA Import Risk Assessment

50.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

8
Total Refusals
2
Unique Violations
8/4/2020
Latest Refusal
12/19/2019
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

25805×

MFRHACCP

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).

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
8/4/2020
16AYD46TURBOT
2580MFRHACCP
Division of West Coast Imports (DWCI)
4/21/2020
16XGC99AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, N.E.C.,
2580MFRHACCP
Division of West Coast Imports (DWCI)
12/20/2019
16AGC16FLOUNDER (ARROWTOOTH, DAB, FLUKE)
83NO PROCESS
Division of West Coast Imports (DWCI)
12/20/2019
16AGC16FLOUNDER (ARROWTOOTH, DAB, FLUKE)
83NO PROCESS
Division of West Coast Imports (DWCI)
12/20/2019
16AGC16FLOUNDER (ARROWTOOTH, DAB, FLUKE)
83NO PROCESS
Division of West Coast Imports (DWCI)
12/19/2019
16AGC16FLOUNDER (ARROWTOOTH, DAB, FLUKE)
2580MFRHACCP
Division of West Coast Imports (DWCI)
12/19/2019
16AGC16FLOUNDER (ARROWTOOTH, DAB, FLUKE)
2580MFRHACCP
Division of West Coast Imports (DWCI)
12/19/2019
16AGC16FLOUNDER (ARROWTOOTH, DAB, FLUKE)
2580MFRHACCP
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is The Ocean Co Ltd's FDA import refusal history?

The Ocean Co Ltd (FEI: 3009807821) has 8 FDA import refusal record(s) in our database, spanning from 12/19/2019 to 8/4/2020.

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. The Ocean Co Ltd's FEI number is 3009807821.

What types of violations has The Ocean Co Ltd received?

The Ocean 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 The Ocean Co Ltd come from?

All FDA import refusal data for The Ocean 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.