Riviera Optical Co Ltd
✅ Low Risk
FEI: 3004643111 • Yung Kang Hsiang, TAINAN • TAIWAN
FEI Number
3004643111
Location
Yung Kang Hsiang, TAINAN
Country
TAIWANAddress
1/F No 10 Alley 2 Lane 279 Chung Cheng R, , Yung Kang Hsiang, TAINAN, Taiwan
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 |
|---|---|---|---|
| 4/3/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 4/3/2015 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 4/3/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Riviera Optical Co Ltd's FDA import refusal history?
Riviera Optical Co Ltd (FEI: 3004643111) has 3 FDA import refusal record(s) in our database, spanning from 4/3/2015 to 4/3/2015.
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. Riviera Optical Co Ltd's FEI number is 3004643111.
What types of violations has Riviera Optical Co Ltd received?
Riviera Optical Co Ltd 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 Riviera Optical Co Ltd come from?
All FDA import refusal data for Riviera Optical Co Ltd 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.