Roithner Lasertechnik
⚠️ Moderate Risk
FEI: 3004134422 • Vienna • AUSTRIA
FEI Number
3004134422
Location
Vienna
Country
AUSTRIAAddress
Schonbrunner Strasse 7b, A-1040, , Vienna, , Austria
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
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NO TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2014 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 1/24/2014 | 95RZNGENERAL INDUSTRIAL USE MATERIAL PROCESSING LASER PRODUCTS | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 6/28/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 12/14/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | New York District Office (NYK-DO) | |
| 10/22/2004 | 95L30LASER PRINTERS | 47NON STD | New York District Office (NYK-DO) |
| 8/12/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Roithner Lasertechnik's FDA import refusal history?
Roithner Lasertechnik (FEI: 3004134422) has 6 FDA import refusal record(s) in our database, spanning from 8/12/2003 to 1/24/2014.
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. Roithner Lasertechnik's FEI number is 3004134422.
What types of violations has Roithner Lasertechnik received?
Roithner Lasertechnik 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 Roithner Lasertechnik come from?
All FDA import refusal data for Roithner Lasertechnik 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.