BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD
⚠️ Moderate Risk
FEI: 3007124039 • YUNG-KANG CITY • TAIWAN
FEI Number
3007124039
Location
YUNG-KANG CITY
Country
TAIWANAddress
NO. 32,LANE 86, CHENG-NAN 2ND ROAD, YUNG-KANG, TAINAN, 710, TAIWAN, R.O.C., YUNG-KANG CITY, , Taiwan
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
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/20/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 11/20/2013 | 86HOISPECTACLE, MAGNIFYING | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD's FDA import refusal history?
BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD (FEI: 3007124039) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2013 to 12/23/2013.
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. BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD's FEI number is 3007124039.
What types of violations has BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD received?
BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD 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 BRIGHTING INTERNATIONAL ADVANTAGE CO., LTD come from?
All FDA import refusal data for BRIGHTING INTERNATIONAL ADVANTAGE 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.