Optical Shop Of Aspen Intl
✅ Low Risk
FEI: 3003365131 • Aliso Viejo, CA • UNITED STATES
FEI Number
3003365131
Location
Aliso Viejo, CA
Country
UNITED STATESAddress
25 Brookline, , Aliso Viejo, CA, United States
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 |
|---|---|---|---|
| 5/21/2002 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Optical Shop Of Aspen Intl's FDA import refusal history?
Optical Shop Of Aspen Intl (FEI: 3003365131) has 1 FDA import refusal record(s) in our database, spanning from 5/21/2002 to 5/21/2002.
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. Optical Shop Of Aspen Intl's FEI number is 3003365131.
What types of violations has Optical Shop Of Aspen Intl received?
Optical Shop Of Aspen Intl 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 Optical Shop Of Aspen Intl come from?
All FDA import refusal data for Optical Shop Of Aspen Intl 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.