Lotas Co Ltd
⚠️ High Risk
FEI: 3003750265 • Kagoshima • JAPAN
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2004 | 16AVT79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Los Angeles District Office (LOS-DO) |
| 4/15/2004 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/15/2004 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/15/2004 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 4/15/2004 | 16AVC79YELLOWTAIL, AMBERJACK | 308MFR INSAN | New York District Office (NYK-DO) |
| 6/11/2003 | 16AVT79YELLOWTAIL, AMBERJACK | 308MFR INSAN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Lotas Co Ltd's FDA import refusal history?
Lotas Co Ltd (FEI: 3003750265) has 6 FDA import refusal record(s) in our database, spanning from 6/11/2003 to 8/31/2004.
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. Lotas Co Ltd's FEI number is 3003750265.
What types of violations has Lotas Co Ltd received?
Lotas Co Ltd has been cited for 1 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 Lotas Co Ltd come from?
All FDA import refusal data for Lotas 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.