Lotte Company, Ltd.
⚠️ Moderate Risk
FEI: 1000266106 • Shinjuku, Tokyo • JAPAN
FEI Number
1000266106
Location
Shinjuku, Tokyo
Country
JAPANAddress
3 Chome 20-1, Nishishinjuku, Shinjuku, Tokyo, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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)).
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.
FLAVR LBLG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2023 | 33UYY01BUBBLE GUM (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of West Coast Imports (DWCI) |
| 11/21/2022 | 03JGT02CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Division of West Coast Imports (DWCI) |
| 4/16/2018 | 33UYT02CHEWING GUM (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 33UYT99CHEWING GUM, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of West Coast Imports (DWCI) |
| 2/13/2017 | 33UYT99CHEWING GUM, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | Division of West Coast Imports (DWCI) |
| 2/15/2012 | 33UGT01BUBBLE GUM (WITHOUT CHOCOLATE) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 10/10/2007 | 33UGT01BUBBLE GUM (WITHOUT CHOCOLATE) | San Francisco District Office (SAN-DO) | |
| 5/7/2007 | 33UGT01BUBBLE GUM (WITHOUT CHOCOLATE) | San Francisco District Office (SAN-DO) | |
| 4/2/2002 | 33YDN99CANDY WITHOUT CHOCOLATE N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/2/2002 | 33EDN99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Lotte Company, Ltd.'s FDA import refusal history?
Lotte Company, Ltd. (FEI: 1000266106) has 10 FDA import refusal record(s) in our database, spanning from 4/2/2002 to 11/14/2023.
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 Company, Ltd.'s FEI number is 1000266106.
What types of violations has Lotte Company, Ltd. received?
Lotte Company, 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 Lotte Company, Ltd. come from?
All FDA import refusal data for Lotte Company, 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.