Primex ehf.
⚠️ High Risk
FEI: 3004327123 • Fjallabyggd • ICELAND
FEI Number
3004327123
Location
Fjallabyggd
Country
ICELANDAddress
Oskarsgata 7, , Fjallabyggd, , Iceland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 Primex ehf.'s FDA import refusal history?
Primex ehf. (FEI: 3004327123) has 2 FDA import refusal record(s) in our database, spanning from 4/22/2003 to 11/16/2023.
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. Primex ehf.'s FEI number is 3004327123.
What types of violations has Primex ehf. received?
Primex ehf. 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 Primex ehf. come from?
All FDA import refusal data for Primex ehf. 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.