GE Healthcare Finland Oy
✅ Low Risk
FEI: 3004971868 • Tuusula, Uusimaa • FINLAND
FEI Number
3004971868
Location
Tuusula, Uusimaa
Country
FINLANDAddress
Pl 20, , Tuusula, Uusimaa, Finland
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is GE Healthcare Finland Oy's FDA import refusal history?
GE Healthcare Finland Oy (FEI: 3004971868) has 1 FDA import refusal record(s) in our database, spanning from 4/28/2020 to 4/28/2020.
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. GE Healthcare Finland Oy's FEI number is 3004971868.
What types of violations has GE Healthcare Finland Oy received?
GE Healthcare Finland Oy 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 GE Healthcare Finland Oy come from?
All FDA import refusal data for GE Healthcare Finland Oy 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.