HAARKLINIK GMBH
⚠️ Moderate Risk
FEI: 3032071596 • Zurich, Zurich • SWITZERLAND
FEI Number
3032071596
Location
Zurich, Zurich
Country
SWITZERLANDAddress
Pfingstweidstrasse 60a, , Zurich, Zurich, Switzerland
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2024 | 95RAALASER PRODUCTS (PRE-STANDARD) | Division of Southeast Imports (DSEI) | |
| 10/16/2024 | 95RAALASER PRODUCTS (PRE-STANDARD) | Division of Southeast Imports (DSEI) | |
| 10/16/2024 | 95RAALASER PRODUCTS (PRE-STANDARD) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HAARKLINIK GMBH's FDA import refusal history?
HAARKLINIK GMBH (FEI: 3032071596) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2024 to 10/16/2024.
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. HAARKLINIK GMBH's FEI number is 3032071596.
What types of violations has HAARKLINIK GMBH received?
HAARKLINIK 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 HAARKLINIK GMBH come from?
All FDA import refusal data for HAARKLINIK 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.