Orifice Medical AB
⚠️ Moderate Risk
FEI: 3002807820 • Ystad, Skane Lan • SWEDEN
FEI Number
3002807820
Location
Ystad, Skane Lan
Country
SWEDENAddress
Aktergatan 2, , Ystad, Skane Lan, 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
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
Frequently Asked Questions
What is Orifice Medical AB's FDA import refusal history?
Orifice Medical AB (FEI: 3002807820) has 2 FDA import refusal record(s) in our database, spanning from 4/22/2003 to 4/22/2003.
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. Orifice Medical AB's FEI number is 3002807820.
What types of violations has Orifice Medical AB received?
Orifice Medical AB 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 Orifice Medical AB come from?
All FDA import refusal data for Orifice Medical AB 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.