ZENITH Baltas- Tsamados S.A.
⚠️ Moderate Risk
FEI: 3004258230 • Peristeri • 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.
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2011 | 20ACP09GRAPES (BERRY) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 3/26/2007 | 02DEE99RICE, PROCESSED (PACKAGED) N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 3/26/2007 | 02DEE99RICE, PROCESSED (PACKAGED) N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/29/2005 | 24TEE99LEAF & STEM VEGETABLES, N.E.C. | Florida District Office (FLA-DO) | |
| 6/29/2005 | 24AEE05FAVA BEAN | Florida District Office (FLA-DO) | |
| 4/10/2003 | 50AGT01COLOR FOR FOODS, DRUGS AND COSMETICS (FD&C) (CERTIFIED) | 11UNSAFE COL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ZENITH Baltas- Tsamados S.A.'s FDA import refusal history?
ZENITH Baltas- Tsamados S.A. (FEI: 3004258230) has 6 FDA import refusal record(s) in our database, spanning from 4/10/2003 to 6/6/2011.
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. ZENITH Baltas- Tsamados S.A.'s FEI number is 3004258230.
What types of violations has ZENITH Baltas- Tsamados S.A. received?
ZENITH Baltas- Tsamados S.A. has been cited for 3 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 ZENITH Baltas- Tsamados S.A. come from?
All FDA import refusal data for ZENITH Baltas- Tsamados 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.