Japan Spectacles & Popular Optic
⚠️ Moderate Risk
FEI: 3004786891 • Osaka, Osaka • JAPAN
FEI Number
3004786891
Location
Osaka, Osaka
Country
JAPANAddress
5-12, Oimazatonishi; Higashinari, Osaka, Osaka, Japan
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQZFRAME, SPECTACLE | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQZFRAME, SPECTACLE | San Francisco District Office (SAN-DO) | |
| 5/12/2015 | 86HQZFRAME, SPECTACLE | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Japan Spectacles & Popular Optic's FDA import refusal history?
Japan Spectacles & Popular Optic (FEI: 3004786891) has 8 FDA import refusal record(s) in our database, spanning from 5/12/2015 to 5/12/2015.
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. Japan Spectacles & Popular Optic's FEI number is 3004786891.
What types of violations has Japan Spectacles & Popular Optic received?
Japan Spectacles & Popular Optic 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 Japan Spectacles & Popular Optic come from?
All FDA import refusal data for Japan Spectacles & Popular Optic 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.