K.IRAKLIDIS & SONS SA
⚠️ High Risk
FEI: 3007679314 • Korinos • GREECE
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 12/14/2010 | 21ACT22PIT AND VINE FRUIT, MIXED | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21ACT22PIT AND VINE FRUIT, MIXED | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21ACT22PIT AND VINE FRUIT, MIXED | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21ACT22PIT AND VINE FRUIT, MIXED | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21ACT22PIT AND VINE FRUIT, MIXED | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21ACT22PIT AND VINE FRUIT, MIXED | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT09OLIVES (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT12STUFFED OLIVE (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT12STUFFED OLIVE (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT12STUFFED OLIVE (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT12STUFFED OLIVE (PIT FRUIT) | Seattle District Office (SEA-DO) | |
| 12/14/2010 | 21GCT12STUFFED OLIVE (PIT FRUIT) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is K.IRAKLIDIS & SONS SA's FDA import refusal history?
K.IRAKLIDIS & SONS SA (FEI: 3007679314) has 20 FDA import refusal record(s) in our database, spanning from 12/14/2010 to 12/14/2010.
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. K.IRAKLIDIS & SONS SA's FEI number is 3007679314.
What types of violations has K.IRAKLIDIS & SONS SA received?
K.IRAKLIDIS & SONS SA 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 K.IRAKLIDIS & SONS SA come from?
All FDA import refusal data for K.IRAKLIDIS & SONS SA 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.