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Novo Nordisk A/S - Hax

⚠️ Moderate Risk

FEI: 3002807748 • Gentofte, Hovedstaden • DENMARK

FEI

FEI Number

3002807748

📍

Location

Gentofte, Hovedstaden

🇩🇰

Country

DENMARK
🏢

Address

Hagedornsvej 1, , Gentofte, Hovedstaden, Denmark

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/2/2022
Latest Refusal
8/3/2020
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
5.9×20%
Frequency
13.3×10%
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

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

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
2/2/2022
64RCY21SOMATROPIN (HORMONE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/3/2020
64RCK21SOMATROPIN (HORMONE)
342PERSONALRX
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Novo Nordisk A/S - Hax's FDA import refusal history?

Novo Nordisk A/S - Hax (FEI: 3002807748) has 2 FDA import refusal record(s) in our database, spanning from 8/3/2020 to 2/2/2022.

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. Novo Nordisk A/S - Hax's FEI number is 3002807748.

What types of violations has Novo Nordisk A/S - Hax received?

Novo Nordisk A/S - Hax 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 Novo Nordisk A/S - Hax come from?

All FDA import refusal data for Novo Nordisk A/S - Hax 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.