Ge Health Care
⚠️ Moderate Risk
FEI: 3005119000 • Uppsala, Uppsala Lan • SWEDEN
FEI Number
3005119000
Location
Uppsala, Uppsala Lan
Country
SWEDENAddress
Bjorkgatan 30, , Uppsala, Uppsala 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2014 | 57VL02REAGENT RED BLOOD CELLS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/8/2014 | 57VL02REAGENT RED BLOOD CELLS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/8/2014 | 75JJHCLINICAL SAMPLE CONCENTRATOR | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/4/2014 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/4/2014 | 57VL02REAGENT RED BLOOD CELLS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/20/2011 | 81KSFKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ge Health Care's FDA import refusal history?
Ge Health Care (FEI: 3005119000) has 6 FDA import refusal record(s) in our database, spanning from 10/20/2011 to 12/8/2014.
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 Health Care's FEI number is 3005119000.
What types of violations has Ge Health Care received?
Ge Health Care 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 Health Care come from?
All FDA import refusal data for Ge Health Care 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.