Joimax GmbH
⚠️ Moderate Risk
FEI: 3005083075 • Karlsruhe, Baden-Wurttemberg • GERMANY
FEI Number
3005083075
Location
Karlsruhe, Baden-Wurttemberg
Country
GERMANYAddress
Raumfabrik 61, Amalienbadstr. 41, Karlsruhe, Baden-Wurttemberg, 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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2024 | 79FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO | 47NON STD | Division of Southeast Imports (DSEI) |
| 12/13/2021 | 62HAY99ANTI-MICROBIAL N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/1/2020 | 90LMBDEVICE, DIGITAL IMAGE STORAGE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Joimax GmbH's FDA import refusal history?
Joimax GmbH (FEI: 3005083075) has 3 FDA import refusal record(s) in our database, spanning from 12/1/2020 to 8/20/2024.
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. Joimax GmbH's FEI number is 3005083075.
What types of violations has Joimax GmbH received?
Joimax 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 Joimax GmbH come from?
All FDA import refusal data for Joimax 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.