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Zao Odesskyi

⚠️ Moderate Risk

FEI: 3004136638 • Odessa City • UKRAINE

FEI

FEI Number

3004136638

📍

Location

Odessa City

🇺🇦

Country

UKRAINE
🏢

Address

22 Vodoprovodnaia, , Odessa City, , Ukraine

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
11/26/2003
Latest Refusal
11/26/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

621×

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).

831×

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

DateProductViolationsDivision
11/26/2003
24FCE07PEPPER, SWEET (FRUIT USED AS VEGETABLE)
62NEEDS FCE
83NO PROCESS
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Zao Odesskyi's FDA import refusal history?

Zao Odesskyi (FEI: 3004136638) has 1 FDA import refusal record(s) in our database, spanning from 11/26/2003 to 11/26/2003.

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. Zao Odesskyi's FEI number is 3004136638.

What types of violations has Zao Odesskyi received?

Zao Odesskyi 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 Zao Odesskyi come from?

All FDA import refusal data for Zao Odesskyi 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.