Statens Seruminstitut
⚠️ Moderate Risk
FEI: 1000204536 • Copenhagen • DENMARK
FEI Number
1000204536
Location
Copenhagen
Country
DENMARKAddress
2770 Kastrup, Artillerivej 5, Copenhagen, , Denmark
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
Frequently Asked Questions
What is Statens Seruminstitut's FDA import refusal history?
Statens Seruminstitut (FEI: 1000204536) has 2 FDA import refusal record(s) in our database, spanning from 8/19/2003 to 3/14/2005.
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. Statens Seruminstitut's FEI number is 1000204536.
What types of violations has Statens Seruminstitut received?
Statens Seruminstitut 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 Statens Seruminstitut come from?
All FDA import refusal data for Statens Seruminstitut 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.