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LOTTE BAKERY INC

⚠️ Moderate Risk

FEI: 3010118203 • Yeonje District, Busan • SOUTH KOREA

FEI

FEI Number

3010118203

📍

Location

Yeonje District, Busan

🇰🇷
🏢

Address

266 Geo-Je-Dae-Ro, , Yeonje District, Busan, South Korea

Moderate Risk

FDA Import Risk Assessment

46.0
LowModerateHighCritical

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

Statistics

10
Total Refusals
4
Unique Violations
3/3/2016
Latest Refusal
7/30/2013
Earliest Refusal

Score Breakdown

Violation Severity
76.4×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
38.5×10%
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

118×

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).

2181×

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.

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.

3241×

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)).

Refusal History

DateProductViolationsDivision
3/3/2016
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
10/19/2015
33CGT99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
10/19/2015
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
9/16/2015
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
8/27/2015
33CGT99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
8/27/2015
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
8/11/2015
33CGT99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
8/11/2015
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Los Angeles District Office (LOS-DO)
5/12/2014
07THT02POTATO STARCH SNACKS, FRIED/OIL COOK
324NO ENGLISH
Los Angeles District Office (LOS-DO)
7/30/2013
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is LOTTE BAKERY INC's FDA import refusal history?

LOTTE BAKERY INC (FEI: 3010118203) has 10 FDA import refusal record(s) in our database, spanning from 7/30/2013 to 3/3/2016.

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. LOTTE BAKERY INC's FEI number is 3010118203.

What types of violations has LOTTE BAKERY INC received?

LOTTE BAKERY INC 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 LOTTE BAKERY INC come from?

All FDA import refusal data for LOTTE BAKERY INC 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.