Opto-Alpha
⚠️ Moderate Risk
FEI: 3008890792 • Tokyo • 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2011 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 231LENS CERT | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Opto-Alpha's FDA import refusal history?
Opto-Alpha (FEI: 3008890792) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2011 to 10/28/2011.
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. Opto-Alpha's FEI number is 3008890792.
What types of violations has Opto-Alpha received?
Opto-Alpha 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 Opto-Alpha come from?
All FDA import refusal data for Opto-Alpha 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.