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World Way Company Limited

⚠️ Moderate Risk

FEI: 3004066276 • Chung Nam Province • SOUTH KOREA

FEI

FEI Number

3004066276

📍

Location

Chung Nam Province

🇰🇷
🏢

Address

618 Shinjeong Ri Jeonui Industrial, , Chung Nam Province, , South Korea

Moderate Risk

FDA Import Risk Assessment

25.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
5
Unique Violations
11/17/2004
Latest Refusal
7/25/2003
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
15.2×10%
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

3242×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/17/2004
30YEE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
260FALSE
324NO ENGLISH
Los Angeles District Office (LOS-DO)
7/25/2003
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
324NO ENGLISH
482NUTRIT LBL
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is World Way Company Limited's FDA import refusal history?

World Way Company Limited (FEI: 3004066276) has 2 FDA import refusal record(s) in our database, spanning from 7/25/2003 to 11/17/2004.

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. World Way Company Limited's FEI number is 3004066276.

What types of violations has World Way Company Limited received?

World Way Company Limited has been cited for 5 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 World Way Company Limited come from?

All FDA import refusal data for World Way Company Limited 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.