Furuta confectionary Co.,Ltd
⚠️ Moderate Risk
FEI: 3005404690 • Osaka, JP-27 • JAPAN
FEI Number
3005404690
Location
Osaka, JP-27
Country
JAPANAddress
,6-Chome,Hayashiji,Ikuno-Ku,Osaka, 7 22, Osaka, JP-27, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2013 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 35AHT03AGAR AGAR (GELATIN PRODUCT) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/18/2003 | 35AHT03AGAR AGAR (GELATIN PRODUCT) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Furuta confectionary Co.,Ltd's FDA import refusal history?
Furuta confectionary Co.,Ltd (FEI: 3005404690) has 3 FDA import refusal record(s) in our database, spanning from 2/18/2003 to 8/15/2013.
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. Furuta confectionary Co.,Ltd's FEI number is 3005404690.
What types of violations has Furuta confectionary Co.,Ltd received?
Furuta confectionary Co.,Ltd has been cited for 2 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 Furuta confectionary Co.,Ltd come from?
All FDA import refusal data for Furuta confectionary 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.