Opal Sy International Ltd
⚠️ Moderate Risk
FEI: 3001744149 • Moshav Bazra • ISRAEL
FEI Number
3001744149
Location
Moshav Bazra
Country
ISRAELAddress
209 Moshav Bazra, , Moshav Bazra, , Israel
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2002 | 24FCE50TOMATOES (FRUIT USED AS VEGETABLE) | Southwest Import District Office (SWI-DO) | |
| 8/4/2002 | 21GCE99PIT FRUIT, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 8/4/2002 | 24FCE08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | 62NEEDS FCE | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Opal Sy International Ltd's FDA import refusal history?
Opal Sy International Ltd (FEI: 3001744149) has 3 FDA import refusal record(s) in our database, spanning from 8/4/2002 to 8/4/2002.
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. Opal Sy International Ltd's FEI number is 3001744149.
What types of violations has Opal Sy International Ltd received?
Opal Sy International 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 Opal Sy International Ltd come from?
All FDA import refusal data for Opal Sy International 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.