Heiwa Bussan Co Ltd
⚠️ Moderate Risk
FEI: 3003502709 • Osaka, Osaka • JAPAN
FEI Number
3003502709
Location
Osaka, Osaka
Country
JAPANAddress
3 Chome 3-8, Nakamoto; Higashinari, Osaka, Osaka, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/22/2002 | 30GEE99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Heiwa Bussan Co Ltd's FDA import refusal history?
Heiwa Bussan Co Ltd (FEI: 3003502709) has 1 FDA import refusal record(s) in our database, spanning from 2/22/2002 to 2/22/2002.
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. Heiwa Bussan Co Ltd's FEI number is 3003502709.
What types of violations has Heiwa Bussan Co Ltd received?
Heiwa Bussan 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 Heiwa Bussan Co Ltd come from?
All FDA import refusal data for Heiwa Bussan 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.