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WELLBEING CONFECTIONERY CO.,LTD

⚠️ Moderate Risk

FEI: 2000042298 • ULSAN, KR-31 • SOUTH KOREA

FEI

FEI Number

2000042298

📍

Location

ULSAN, KR-31

🇰🇷
🏢

Address

ADONG 898 JOILEE SANGDONG MYUN ULJUGUN, ULSAN, ULSAN, KR-31, South Korea

Moderate Risk

FDA Import Risk Assessment

41.5
LowModerateHighCritical

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

Statistics

10
Total Refusals
5
Unique Violations
11/22/2011
Latest Refusal
9/17/2008
Earliest Refusal

Score Breakdown

Violation Severity
66.9×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
31.4×10%
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

119×

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).

2743×

COLOR LBLG

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

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)).

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

33201×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

Refusal History

DateProductViolationsDivision
11/22/2011
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Los Angeles District Office (LOS-DO)
11/22/2011
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Los Angeles District Office (LOS-DO)
11/22/2011
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
6/30/2009
33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
324NO ENGLISH
Los Angeles District Office (LOS-DO)
6/30/2009
33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
5/22/2009
33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
5/11/2009
33EGY06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
324NO ENGLISH
Los Angeles District Office (LOS-DO)
2/24/2009
33LGY06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
9/17/2008
33LGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
320LACKS FIRM
3320TRANSFAT
Los Angeles District Office (LOS-DO)
9/17/2008
33LGY06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is WELLBEING CONFECTIONERY CO.,LTD's FDA import refusal history?

WELLBEING CONFECTIONERY CO.,LTD (FEI: 2000042298) has 10 FDA import refusal record(s) in our database, spanning from 9/17/2008 to 11/22/2011.

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. WELLBEING CONFECTIONERY CO.,LTD's FEI number is 2000042298.

What types of violations has WELLBEING CONFECTIONERY CO.,LTD received?

WELLBEING CONFECTIONERY CO.,LTD 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 WELLBEING CONFECTIONERY CO.,LTD come from?

All FDA import refusal data for WELLBEING 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.