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Lotte Co.

⚠️ Moderate Risk

FEI: 3003092848 • Shinjyuku, Tokyo • JAPAN

FEI

FEI Number

3003092848

📍

Location

Shinjyuku, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

3 21-1, Nishi, Shinjyuku, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/2/2002
Latest Refusal
4/2/2002
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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).

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.

2581×

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.

Refusal History

DateProductViolationsDivision
4/2/2002
33EFY12MIXED/ASSORTED HARD CANDY WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
258FLAVR LBLG
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Lotte Co.'s FDA import refusal history?

Lotte Co. (FEI: 3003092848) has 1 FDA import refusal record(s) in our database, spanning from 4/2/2002 to 4/2/2002.

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 Co.'s FEI number is 3003092848.

What types of violations has Lotte Co. received?

Lotte Co. has been cited for 3 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 Co. come from?

All FDA import refusal data for Lotte Co. 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.