Astra Zeneca Kft
⚠️ Moderate Risk
FEI: 3005615782 • Budapestbudapest • HUNGARY
FEI Number
3005615782
Location
Budapestbudapest
Country
HUNGARYAddress
Park U3, , Budapestbudapest, , Hungary
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
Frequently Asked Questions
What is Astra Zeneca Kft's FDA import refusal history?
Astra Zeneca Kft (FEI: 3005615782) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2007 to 10/30/2007.
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. Astra Zeneca Kft's FEI number is 3005615782.
What types of violations has Astra Zeneca Kft received?
Astra Zeneca Kft 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 Astra Zeneca Kft come from?
All FDA import refusal data for Astra Zeneca Kft 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.