ASTRA ZENAECA SWEDEN OPERATIONS
⚠️ Moderate Risk
FEI: 3012920149 • Sodertalje • SWEDEN
FEI Number
3012920149
Location
Sodertalje
Country
SWEDENAddress
Bldg 337/3 SE 151 85, , Sodertalje, , Sweden
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 ZENAECA SWEDEN OPERATIONS's FDA import refusal history?
ASTRA ZENAECA SWEDEN OPERATIONS (FEI: 3012920149) has 2 FDA import refusal record(s) in our database, spanning from 12/8/2020 to 3/12/2021.
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 ZENAECA SWEDEN OPERATIONS's FEI number is 3012920149.
What types of violations has ASTRA ZENAECA SWEDEN OPERATIONS received?
ASTRA ZENAECA SWEDEN OPERATIONS 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 ZENAECA SWEDEN OPERATIONS come from?
All FDA import refusal data for ASTRA ZENAECA SWEDEN OPERATIONS 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.