RK Design Optik Gmbh
✅ Low Risk
FEI: 3001748277 • Weil der Stadt, Baden-Wurttemberg • GERMANY
FEI Number
3001748277
Location
Weil der Stadt, Baden-Wurttemberg
Country
GERMANYAddress
Forchenrain 11/2, , Weil der Stadt, Baden-Wurttemberg, Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 4/22/2014 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is RK Design Optik Gmbh's FDA import refusal history?
RK Design Optik Gmbh (FEI: 3001748277) has 1 FDA import refusal record(s) in our database, spanning from 4/22/2014 to 4/22/2014.
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. RK Design Optik Gmbh's FEI number is 3001748277.
What types of violations has RK Design Optik Gmbh received?
RK Design Optik Gmbh has been cited for 1 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 RK Design Optik Gmbh come from?
All FDA import refusal data for RK Design Optik 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.