AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO
⚠️ Moderate Risk
FEI: 3004306414 • Etoliko, Dytiki Ellada • GREECE
FEI Number
3004306414
Location
Etoliko, Dytiki Ellada
Country
GREECEAddress
Kefalovryso,Etoliko, , Etoliko, Dytiki Ellada, 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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
USUAL NAME
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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).
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2020 | 21GGI11OLIVES, GREEN, (PIT FRUIT) | 249FILTHY | Division of Southeast Imports (DSEI) |
| 8/14/2012 | 28BFH27MARJORAM, GROUND, CRACKED (SPICE) | Detroit District Office (DET-DO) | |
| 12/27/2007 | 21GHT09OLIVES (PIT FRUIT) | 249FILTHY | Detroit District Office (DET-DO) |
| 5/10/2004 | 21GCI09OLIVES (PIT FRUIT) | New York District Office (NYK-DO) | |
| 4/5/2004 | 25ECE99MIXED VEGETABLES, N.E.C. | 83NO PROCESS | Detroit District Office (DET-DO) |
| 4/5/2004 | 25ECE99MIXED VEGETABLES, N.E.C. | 83NO PROCESS | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO's FDA import refusal history?
AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO (FEI: 3004306414) has 6 FDA import refusal record(s) in our database, spanning from 4/5/2004 to 3/25/2020.
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. AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO's FEI number is 3004306414.
What types of violations has AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO received?
AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO has been cited for 6 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 AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO come from?
All FDA import refusal data for AMALTHIA S.A. INDUSTRIAL &COMMERCIAL ENTERPR.OF AGRICULT.PRO 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.