Hoelzel Diagnostika Handels Gmbh
⚠️ Moderate Risk
FEI: 3010985629 • K�ln, Nordrhein-westfalen • GERMANY
FEI Number
3010985629
Location
K�ln, Nordrhein-westfalen
Country
GERMANYAddress
38 Hohenzollernring, , K�ln, Nordrhein-westfalen, 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).
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
Frequently Asked Questions
What is Hoelzel Diagnostika Handels Gmbh's FDA import refusal history?
Hoelzel Diagnostika Handels Gmbh (FEI: 3010985629) has 2 FDA import refusal record(s) in our database, spanning from 12/31/2014 to 4/9/2015.
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. Hoelzel Diagnostika Handels Gmbh's FEI number is 3010985629.
What types of violations has Hoelzel Diagnostika Handels Gmbh received?
Hoelzel Diagnostika Handels Gmbh 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 Hoelzel Diagnostika Handels Gmbh come from?
All FDA import refusal data for Hoelzel Diagnostika Handels Gmbh 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.