VENEERA GMBH
⚠️ High Risk
FEI: 3033088477 • Cologne, North Rhine-Westphalia • GERMANY
FEI Number
3033088477
Location
Cologne, North Rhine-Westphalia
Country
GERMANYAddress
Frohnhofweg 15, , Cologne, North Rhine-Westphalia, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | Division of Southeast Imports (DSEI) | |
| 2/18/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | Division of Southeast Imports (DSEI) | |
| 2/7/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | Division of Southeast Imports (DSEI) | |
| 1/16/2025 | 76ELMDENTURE, PLASTIC, TEETH | Division of Southeast Imports (DSEI) | |
| 1/10/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/8/2025 | 76EKODENTURE PREFORMED (PARTIALLY PREFABRICATED DENTURE) | Division of Southeast Imports (DSEI) | |
| 1/8/2025 | 76NSKDENTURES, PARTIAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VENEERA GMBH's FDA import refusal history?
VENEERA GMBH (FEI: 3033088477) has 7 FDA import refusal record(s) in our database, spanning from 1/8/2025 to 2/21/2025.
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. VENEERA GMBH's FEI number is 3033088477.
What types of violations has VENEERA GMBH received?
VENEERA GMBH has been cited for 6 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 VENEERA GMBH come from?
All FDA import refusal data for VENEERA 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.