Gaea Products S.A.
⚠️ Moderate Risk
FEI: 3005382557 • Agrinio, Aitoloakarnanias • GREECE
FEI Number
3005382557
Location
Agrinio, Aitoloakarnanias
Country
GREECEAddress
1st Km National Road Agrinion-Karpenisi, , Agrinio, Aitoloakarnanias, Greece
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 |
|---|---|---|---|
| 5/6/2009 | 21HCE99PIT FRUIT, DRIED OR PASTE, N.E.C. | 83NO PROCESS | New York District Office (NYK-DO) |
| 5/6/2009 | 21GCE09OLIVES (PIT FRUIT) | 83NO PROCESS | New York District Office (NYK-DO) |
| 5/6/2009 | 21GCE09OLIVES (PIT FRUIT) | 83NO PROCESS | New York District Office (NYK-DO) |
| 1/29/2003 | 24FCT99FRUITS USED AS VEGETABLES, N.E.C. | 83NO PROCESS | New York District Office (NYK-DO) |
| 1/29/2003 | 21GEE09OLIVES (PIT FRUIT) | 83NO PROCESS | New York District Office (NYK-DO) |
| 1/29/2003 | 21GEE09OLIVES (PIT FRUIT) | 83NO PROCESS | New York District Office (NYK-DO) |
| 1/29/2003 | 21GEE09OLIVES (PIT FRUIT) | 83NO PROCESS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Gaea Products S.A.'s FDA import refusal history?
Gaea Products S.A. (FEI: 3005382557) has 7 FDA import refusal record(s) in our database, spanning from 1/29/2003 to 5/6/2009.
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. Gaea Products S.A.'s FEI number is 3005382557.
What types of violations has Gaea Products S.A. received?
Gaea Products S.A. 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 Gaea Products S.A. come from?
All FDA import refusal data for Gaea Products S.A. 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.