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Novonesis AS

⚠️ Moderate Risk

FEI: 3004275266 • Hvidovre, Hovedstaden • DENMARK

FEI

FEI Number

3004275266

📍

Location

Hvidovre, Hovedstaden

🇩🇰

Country

DENMARK
🏢

Address

Jernholmen 1, 27, , Hvidovre, Hovedstaden, Denmark

Moderate Risk

FDA Import Risk Assessment

48.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
3/4/2024
Latest Refusal
8/21/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
62.9×20%
Frequency
40.0×10%
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

35604×

SUPPL GMP

The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.

Refusal History

DateProductViolationsDivision
3/4/2024
54HCL99FATS AND LIPID SUBSTANCES, N.E.C.
3560SUPPL GMP
Division of Northern Border Imports (DNBI)
11/30/2023
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of Southeast Imports (DSEI)
11/16/2023
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of Southeast Imports (DSEI)
8/21/2023
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Novonesis AS's FDA import refusal history?

Novonesis AS (FEI: 3004275266) has 4 FDA import refusal record(s) in our database, spanning from 8/21/2023 to 3/4/2024.

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. Novonesis AS's FEI number is 3004275266.

What types of violations has Novonesis AS received?

Novonesis AS 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 Novonesis AS come from?

All FDA import refusal data for Novonesis AS 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.