Gurume kenkyujyo
⚠️ Moderate Risk
FEI: 3004650605 • Meguro, Tokyo • JAPAN
FEI Number
3004650605
Location
Meguro, Tokyo
Country
JAPANAddress
1 Chome 3-1 1f, Nakameguro, Meguro, 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
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.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
Refusal History
Frequently Asked Questions
What is Gurume kenkyujyo's FDA import refusal history?
Gurume kenkyujyo (FEI: 3004650605) has 3 FDA import refusal record(s) in our database, spanning from 7/7/2004 to 12/23/2004.
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. Gurume kenkyujyo's FEI number is 3004650605.
What types of violations has Gurume kenkyujyo received?
Gurume kenkyujyo 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 Gurume kenkyujyo come from?
All FDA import refusal data for Gurume kenkyujyo 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.