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Cho Yang Plastic Ind. Co., Ltd.

✅ Low Risk

FEI: 3009713756 • Kyungki Do • SOUTH KOREA

FEI

FEI Number

3009713756

📍

Location

Kyungki Do

🇰🇷
🏢

Address

603-14 Jang Gok Ri Chori Eup Paju, , Kyungki Do, , South Korea

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/14/2012
Latest Refusal
11/14/2012
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/14/2012
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Cho Yang Plastic Ind. Co., Ltd.'s FDA import refusal history?

Cho Yang Plastic Ind. Co., Ltd. (FEI: 3009713756) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2012 to 11/14/2012.

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. Cho Yang Plastic Ind. Co., Ltd.'s FEI number is 3009713756.

What types of violations has Cho Yang Plastic Ind. Co., Ltd. received?

Cho Yang Plastic Ind. 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 Cho Yang Plastic Ind. Co., Ltd. come from?

All FDA import refusal data for Cho Yang Plastic Ind. 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.