RIKEN CHEMICAL INDUSTRY CO., LTD.
⚠️ Moderate Risk
FEI: 3004702679 • Minamiawaji, Hyogo • JAPAN
FEI Number
3004702679
Location
Minamiawaji, Hyogo
Country
JAPANAddress
Hyogo 656-513, Kashunota, Minamiawaji, Hyogo, 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
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
Refusal History
Frequently Asked Questions
What is RIKEN CHEMICAL INDUSTRY CO., LTD.'s FDA import refusal history?
RIKEN CHEMICAL INDUSTRY CO., LTD. (FEI: 3004702679) has 1 FDA import refusal record(s) in our database, spanning from 11/2/2009 to 11/2/2009.
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. RIKEN CHEMICAL INDUSTRY CO., LTD.'s FEI number is 3004702679.
What types of violations has RIKEN CHEMICAL INDUSTRY CO., LTD. received?
RIKEN CHEMICAL INDUSTRY CO., LTD. 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 RIKEN CHEMICAL INDUSTRY CO., LTD. come from?
All FDA import refusal data for RIKEN CHEMICAL INDUSTRY 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.