Optovent AB
⚠️ Moderate Risk
FEI: 3003660454 • Taby, Stockholms Lan • SWEDEN
FEI Number
3003660454
Location
Taby, Stockholms Lan
Country
SWEDENAddress
Stockholmsvagen 116b, , Taby, Stockholms 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
Frequently Asked Questions
What is Optovent AB's FDA import refusal history?
Optovent AB (FEI: 3003660454) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2002 to 7/3/2002.
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. Optovent AB's FEI number is 3003660454.
What types of violations has Optovent AB received?
Optovent AB 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 Optovent AB come from?
All FDA import refusal data for Optovent 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.