ImportRefusal LogoImportRefusal

Changhee Confectionery Co., Ltd.

⚠️ Moderate Risk

FEI: 3004460788 • Namyangju City, Gyeonggido • SOUTH KOREA

FEI

FEI Number

3004460788

📍

Location

Namyangju City, Gyeonggido

🇰🇷
🏢

Address

#20-9, Naebang-ri, Sudong-myun, Namyangju-city, Gyeonggi-do, KOREA, Namyangju City, Gyeonggido, South Korea

Moderate Risk

FDA Import Risk Assessment

30.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
4
Unique Violations
12/1/2008
Latest Refusal
4/23/2008
Earliest Refusal

Score Breakdown

Violation Severity
52.2×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2743×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

643×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

2182×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
12/1/2008
03HGT07MIXED PLAIN COOKIES,BISCUITS AND WAFERS
218LIST INGRE
274COLOR LBLG
64YELLOW #5
Los Angeles District Office (LOS-DO)
12/1/2008
03HGT07MIXED PLAIN COOKIES,BISCUITS AND WAFERS
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
64YELLOW #5
Los Angeles District Office (LOS-DO)
4/23/2008
03HGT07MIXED PLAIN COOKIES,BISCUITS AND WAFERS
274COLOR LBLG
64YELLOW #5
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Changhee Confectionery Co., Ltd. (FEI: 3004460788) has 3 FDA import refusal record(s) in our database, spanning from 4/23/2008 to 12/1/2008.

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. Changhee Confectionery Co., Ltd.'s FEI number is 3004460788.

What types of violations has Changhee Confectionery Co., Ltd. received?

Changhee Confectionery Co., Ltd. has been cited for 4 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 Changhee Confectionery Co., Ltd. come from?

All FDA import refusal data for Changhee Confectionery 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.