Vemed
⚠️ Moderate Risk
FEI: 3009299125 • Giesen, Hesse • GERMANY
FEI Number
3009299125
Location
Giesen, Hesse
Country
GERMANYAddress
Iheringstr. 7, , Giesen, Hesse, Germany
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).
RECORDS
The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Vemed's FDA import refusal history?
Vemed (FEI: 3009299125) has 1 FDA import refusal record(s) in our database, spanning from 5/8/2012 to 5/8/2012.
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. Vemed's FEI number is 3009299125.
What types of violations has Vemed received?
Vemed has been cited for 3 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 Vemed come from?
All FDA import refusal data for Vemed 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.