Sun And Young Sunglasses Co., Ltd.
✅ Low Risk
FEI: 1000182421 • Tainan Hsien • TAIWAN
FEI Number
1000182421
Location
Tainan Hsien
Country
TAIWANAddress
Yungkang, 113, 2nd Floor; Tzu Ching Road, Tainan Hsien, , 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
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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
Frequently Asked Questions
What is Sun And Young Sunglasses Co., Ltd.'s FDA import refusal history?
Sun And Young Sunglasses Co., Ltd. (FEI: 1000182421) has 2 FDA import refusal record(s) in our database, spanning from 6/26/2006 to 6/5/2012.
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. Sun And Young Sunglasses Co., Ltd.'s FEI number is 1000182421.
What types of violations has Sun And Young Sunglasses Co., Ltd. received?
Sun And Young Sunglasses Co., Ltd. has been cited for 2 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 Sun And Young Sunglasses Co., Ltd. come from?
All FDA import refusal data for Sun And Young Sunglasses 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.