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ELIMUS LTD

⚠️ Moderate Risk

FEI: 3016784483 • Sofia, Sofia • BULGARIA

FEI

FEI Number

3016784483

📍

Location

Sofia, Sofia

🇧🇬

Country

BULGARIA
🏢

Address

Adam Mickiewich 4 A, , Sofia, Sofia, Bulgaria

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/29/2020
Latest Refusal
10/29/2020
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/29/2020
54ACY99VITAMIN, N.E.C.
482NUTRIT LBL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ELIMUS LTD's FDA import refusal history?

ELIMUS LTD (FEI: 3016784483) has 1 FDA import refusal record(s) in our database, spanning from 10/29/2020 to 10/29/2020.

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. ELIMUS LTD's FEI number is 3016784483.

What types of violations has ELIMUS LTD received?

ELIMUS LTD 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 ELIMUS LTD come from?

All FDA import refusal data for ELIMUS LTD 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.