ImportRefusal LogoImportRefusal

Astrazeneca

⚠️ High Risk

FEI: 3003689009 • Destelbergen, Oost-Vlaanderen • BELGIUM

FEI

FEI Number

3003689009

📍

Location

Destelbergen, Oost-Vlaanderen

🇧🇪

Country

BELGIUM
🏢

Address

Schaessestraat 15, , Destelbergen, Oost-Vlaanderen, Belgium

High Risk

FDA Import Risk Assessment

55.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
9/20/2024
Latest Refusal
9/20/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
73.5×20%
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

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
9/20/2024
66NCY03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Astrazeneca's FDA import refusal history?

Astrazeneca (FEI: 3003689009) has 1 FDA import refusal record(s) in our database, spanning from 9/20/2024 to 9/20/2024.

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. Astrazeneca's FEI number is 3003689009.

What types of violations has Astrazeneca received?

Astrazeneca 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 Astrazeneca come from?

All FDA import refusal data for Astrazeneca 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.