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Orio Co., Ltd.

✅ Low Risk

FEI: 3004454487 • Seoul • SOUTH KOREA

FEI

FEI Number

3004454487

📍

Location

Seoul

🇰🇷
🏢

Address

130-6 Kangnam-gu Cangdan-dong, , Seoul, , South Korea

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/14/2009
Latest Refusal
9/14/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

2541×

STD QUALIT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(h)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a standard of quality has been prescribed by regulation as provided by Section 401 of the FD&C Act, and its quality falls below such standard and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify.

Refusal History

DateProductViolationsDivision
9/14/2009
03NGT01CAKE,CUSTARD OR CREAM FILLED
254STD QUALIT
New York District Office (NYK-DO)

Frequently Asked Questions

What is Orio Co., Ltd.'s FDA import refusal history?

Orio Co., Ltd. (FEI: 3004454487) has 1 FDA import refusal record(s) in our database, spanning from 9/14/2009 to 9/14/2009.

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. Orio Co., Ltd.'s FEI number is 3004454487.

What types of violations has Orio Co., Ltd. received?

Orio Co., Ltd. has been cited for 1 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 Orio Co., Ltd. come from?

All FDA import refusal data for Orio 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.