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ELKA INTERNATIONAL DOOEL

⚠️ Moderate Risk

FEI: 3036144751 • Skopje • MACEDONIA

FEI

FEI Number

3036144751

📍

Location

Skopje

🇲🇰

Country

MACEDONIA
🏢

Address

Street Bosna I Hercegov, , Skopje, , Macedonia

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/17/2025
Latest Refusal
4/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
85.0×20%
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

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
4/17/2025
03NGT03PASTRY (ECLAIRS, CREAM PUFFS) CUSTARD OR CREAM FILLED
3300ALLERGEN
473LABELING
482NUTRIT LBL
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is ELKA INTERNATIONAL DOOEL's FDA import refusal history?

ELKA INTERNATIONAL DOOEL (FEI: 3036144751) has 1 FDA import refusal record(s) in our database, spanning from 4/17/2025 to 4/17/2025.

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. ELKA INTERNATIONAL DOOEL's FEI number is 3036144751.

What types of violations has ELKA INTERNATIONAL DOOEL received?

ELKA INTERNATIONAL DOOEL 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 ELKA INTERNATIONAL DOOEL come from?

All FDA import refusal data for ELKA INTERNATIONAL DOOEL 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.