Uvex Arbeitsschutz Gmbh
⚠️ Moderate Risk
FEI: 3002829509 • Furth, Bavaria • GERMANY
FEI Number
3002829509
Location
Furth, Bavaria
Country
GERMANYAddress
Wurzburger Str. 181-189, , Furth, Bavaria, 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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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).
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 |
|---|---|---|---|
| 10/15/2012 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 235NOT IMPACT | Chicago District Office (CHI-DO) |
| 10/15/2012 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 235NOT IMPACT | Chicago District Office (CHI-DO) |
| 12/15/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Uvex Arbeitsschutz Gmbh's FDA import refusal history?
Uvex Arbeitsschutz Gmbh (FEI: 3002829509) has 3 FDA import refusal record(s) in our database, spanning from 12/15/2011 to 10/15/2012.
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. Uvex Arbeitsschutz Gmbh's FEI number is 3002829509.
What types of violations has Uvex Arbeitsschutz Gmbh received?
Uvex Arbeitsschutz 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 Uvex Arbeitsschutz Gmbh come from?
All FDA import refusal data for Uvex Arbeitsschutz 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.