INZEK INTERNATIONAL TRADING
⚠️ Moderate Risk
FEI: 3016650379 • Apeldoorn, Gelderland • NETHERLANDS
FEI Number
3016650379
Location
Apeldoorn, Gelderland
Country
NETHERLANDSAddress
Vissenstraat 32, , Apeldoorn, Gelderland, Netherlands
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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/3/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 5/14/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/9/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 4/7/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is INZEK INTERNATIONAL TRADING's FDA import refusal history?
INZEK INTERNATIONAL TRADING (FEI: 3016650379) has 5 FDA import refusal record(s) in our database, spanning from 4/7/2020 to 3/9/2022.
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. INZEK INTERNATIONAL TRADING's FEI number is 3016650379.
What types of violations has INZEK INTERNATIONAL TRADING received?
INZEK INTERNATIONAL TRADING 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 INZEK INTERNATIONAL TRADING come from?
All FDA import refusal data for INZEK INTERNATIONAL TRADING 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.