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DANISH CONSULTANCY

⚠️ Moderate Risk

FEI: 3021943106 • Silkeborg • DENMARK

FEI

FEI Number

3021943106

📍

Location

Silkeborg

🇩🇰

Country

DENMARK
🏢

Address

Chr D 8s Vej 37, , Silkeborg, , Denmark

Moderate Risk

FDA Import Risk Assessment

34.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/29/2022
Latest Refusal
4/29/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
11.9×20%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
4/29/2022
83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DANISH CONSULTANCY's FDA import refusal history?

DANISH CONSULTANCY (FEI: 3021943106) has 1 FDA import refusal record(s) in our database, spanning from 4/29/2022 to 4/29/2022.

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. DANISH CONSULTANCY's FEI number is 3021943106.

What types of violations has DANISH CONSULTANCY received?

DANISH CONSULTANCY has been cited for 1 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 DANISH CONSULTANCY come from?

All FDA import refusal data for DANISH CONSULTANCY 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.