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HOFSETH BIOCARE ASA

⚠️ Moderate Risk

FEI: 3030665515 • Alesund, More og Romsdal • NORWAY

FEI

FEI Number

3030665515

📍

Location

Alesund, More og Romsdal

🇳🇴

Country

NORWAY
🏢

Address

Keiser Wilhelms Gate 24, , Alesund, More og Romsdal, Norway

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/18/2025
Latest Refusal
4/18/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
70.2×20%
Frequency
20.0×10%
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

4732×

LABELING

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

4822×

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
4/18/2025
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
482NUTRIT LBL
Division of Southeast Imports (DSEI)
4/18/2025
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
482NUTRIT LBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HOFSETH BIOCARE ASA's FDA import refusal history?

HOFSETH BIOCARE ASA (FEI: 3030665515) has 2 FDA import refusal record(s) in our database, spanning from 4/18/2025 to 4/18/2025.

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. HOFSETH BIOCARE ASA's FEI number is 3030665515.

What types of violations has HOFSETH BIOCARE ASA received?

HOFSETH BIOCARE ASA 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 HOFSETH BIOCARE ASA come from?

All FDA import refusal data for HOFSETH BIOCARE ASA 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.